Inpeco S.A.: 33 FDA recall reports
Every medical device recall the FDA has published for Inpeco S.A.. The fault, and how the agency graded it.
33Reports
0Class I
17Ongoing
2025-12-03Most recent
What the classes mean
The FDA sorts every recall into one of three classes. The class is the whole story. It is also the part people skip.
Class II is the bulk of every list here. That matters. A long list of Class II says something different from one Class I.
By class
By year reported
Checking whether it affects you
The lot or code number is what matters. Not the product name. A recall covers
specific lots. Yours may not be one of them.
Check the code on your package against the report. The FDA keeps the current
list at fda.gov/safety/recalls.
The reports
The text below is quoted from the FDA record word for word.
FlexLab (FLX); Version: FLX-217-40;
Z-0596-2026 · Class II · reported 2025-12-03 · Ongoing
- Why it was recalled
- The Aliquoter Module (mALX) may generate secondary sample tubes without labels or with mismatched labels which may result in delayed results or erroneous results, this error occurs if the operators open the printer head of mALX to perform error recoveries or maintenance procedures and do not empty the printer tubes buffer to remove all the secondary sample tubes
- Product
- FlexLab (FLX); Version: FLX-217-40;
- Where it went
- US Domestic: MI. OUS International: Australia, Finland, France, Germany, Italy, Portugal, Spain, and UK.
- How much
- 14 units (1 US, 13 OUS)
FlexLab (FLX); Version: FLX-217-10;
Z-0595-2026 · Class II · reported 2025-12-03 · Ongoing
- Why it was recalled
- The Aliquoter Module (mALX) may generate secondary sample tubes without labels or with mismatched labels which may result in delayed results or erroneous results. This error occurs if the operators open the printer head of mALX to perform error recoveries or maintenance procedures and do not empty the printer tubes buffer to remove all the secondary sample tubes.
- Product
- FlexLab (FLX); Version: FLX-217-10;
- Where it went
- US Domestic: MI. OUS International: Australia, Finland, France, Germany, Italy, Portugal, Spain, and UK.
- How much
- 1 unit (OUS only)
FlexLab X (FXX) System. Potassium Test System. in vitro diagnostic
Z-0107-2026 · Class II · reported 2025-10-15 · Ongoing
- Why it was recalled
- The FlexLab X System Sample Integrity Module (SIM) includes function that determines the hemolysis, icterus, and lipemia (HIL) in blood samples. This function has not been evaluated for safety and effectiveness by the FDA, so its use may cause an increase in erroneous results or a delay in patient results.
- Product
- FlexLab X (FXX) System. Potassium Test System. in vitro diagnostic
- Where it went
- US distribution to CA & NY.
- How much
- 1 unit
FlexLab (FLX) System. Potassium Test System. in vitro diagnostic
Z-0106-2026 · Class II · reported 2025-10-15 · Ongoing
- Why it was recalled
- The FlexLab System Sample Integrity Module (SIM) includes function that determines the hemolysis, icterus, and lipemia (HIL) in blood samples. This function has not been evaluated for safety and effectiveness by the FDA, so its use may cause an increase in erroneous results or a delay in patient results.
- Product
- FlexLab (FLX) System. Potassium Test System. in vitro diagnostic
- Where it went
- US distribution to CA & NY.
- How much
- 8 units
Roche Cobas 8000 and Cobas PRO Interface Module (CO8 IM)- IVD FlexLab Automation System -a modular system desi
Z-0560-2024 · Class II · reported 2023-12-27 · Ongoing
- Why it was recalled
- Firmware of the Interface Module with Roche Cobas 8000 and Cobas PRO (CO8 IM) may lead to a delayed sample tube processing.
- Product
- Roche Cobas 8000 and Cobas PRO Interface Module (CO8 IM)- IVD FlexLab Automation System -a modular system designed to automate Pre-Analytical and Post-Analytical processing, sample handling in order to automate sample processing in the Laboratory. Hardware versions: FLX-247-00 Firmware versions: COBASa_2.2.0, COBASa_2.3.0
- Where it went
- Worldwide - US Nationwide distribution in the state of MA and the countries of AUSTRIA, BELGIUM, DENMARK, ITALY, NORWAY, SPAIN.
- How much
- 1 unit US: 14 units OUS
Storage and Retrieval Module (SRM)-Laboratory Automation system Brand names of the same product: FlexLab (F
Z-1560-2023 · Class II · reported 2023-05-10 · Ongoing
- Why it was recalled
- Firmware versions have the potential to mis-associate sample IDs leading to incorrect results or delayed sodium, potassium, and chloride patient results. Falsely increased or decreased electrolytes can lead to either inappropriate treatment of normal results, or failure to treat abnormal results resulting in abnormal levels. Abnormal potassium levels can result in weakness, polyuria, ileus, psychiatric disturbances, cardiac arrhythmias, respiratory depression, and death. Abnormal sodium levels can result in CNS disturbances and disturbances of water balance. Abnormal chloride levels can lead to acid base disturbances which can lead to respiratory and cardiac compromise. The event may occur only if all the following conditions occurs in few milliseconds timeframe: - The module is releasing a sample tube (Tube A) just placed into the carrier - Another sample tube (Tube B) is erroneously not diverted into the module buffer lane due to a malfunction of the divert gate Only in this specific scenario, the Tube A may be released by the module as Tube B due to a miscommunication between the module firmware and the Automation software without any error message. The Automation...
- Product
- Storage and Retrieval Module (SRM)-Laboratory Automation system Brand names of the same product: FlexLab (FLX), Accelerator a3600 (ACP), Aptio Automation (AP2) Part Numbers: ACP-207-00, ACP-207-01, ACP-230-00, ACP-230-01 APT-207-00, APT-207-01, APT-230-00, APT-230-01 FLX-207-00, FLX-207-01, FLX-207-02, FLX-230-00, FLX-230-01, FLX-230-02 FLX-207-10, FLX-207-11, FLX-230-10
- Where it went
- Worldwide distribution - US Nationwide and the countries of ARGENTINA, AUSTRALIA, AUSTRIA, BELGIUM, BRAZIL, CANADA, CHILE, CHINA, COLOMBIA, CZECH REPUBLIC, DENMARK, EAU, EGYPT, FRANCE, GERMANY, GREECE, HUNGARY, INDIA, IRELAND, ISRAEL, ITALY, JAPAN, KENYA, MALAYSIA, MEXICO, MYANMAR, NETHERLANDS, NORWAY, OMAN, PAKISTAN, PORTUGAL, QATAR, SAUDI ARABIA, SINGAPORE, SLOVAKIA, SLOVENIA, SOUTH AFRICA, SOUTH KOREA, SPAIN, SWEDEN, SWITZERLAND, TAIWAN, THAILAND, TURKEY, UK, VIETNAM.
- How much
- US: 245 (16 FlexLab systems, 121 Accelerator a3600 system, 108 Aptio Automation systems).
Input Output Module (IOM) FLX-201-Laboratory Automation system Brand names of the same product: FlexLab (FL
Z-1559-2023 · Class II · reported 2023-05-10 · Ongoing
- Why it was recalled
- Firmware versions have the potential to mis-associate sample IDs leading to incorrect results or delayed sodium, potassium, and chloride patient results. Falsely increased or decreased electrolytes can lead to either inappropriate treatment of normal results, or failure to treat abnormal results resulting in abnormal levels. Abnormal potassium levels can result in weakness, polyuria, ileus, psychiatric disturbances, cardiac arrhythmias, respiratory depression, and death. Abnormal sodium levels can result in CNS disturbances and disturbances of water balance. Abnormal chloride levels can lead to acid base disturbances which can lead to respiratory and cardiac compromise. The event may occur only if all the following conditions occurs in few milliseconds timeframe: - The module is releasing a sample tube (Tube A) just placed into the carrier - Another sample tube (Tube B) is erroneously not diverted into the module buffer lane due to a malfunction of the divert gate Only in this specific scenario, the Tube A may be released by the module as Tube B due to a miscommunication between the module firmware and the Automation software without any error message. The Automation...
- Product
- Input Output Module (IOM) FLX-201-Laboratory Automation system Brand names of the same product: FlexLab (FLX), Accelerator a3600 (ACP), Aptio Automation (AP2) Part Numbers: FLX-201-00, APT-201-00, APT-253-00 ACP-201-00, FLX-201-10, FLX-253-10, FLX-253-11
- Where it went
- Worldwide distribution - US Nationwide and the countries of ARGENTINA, AUSTRALIA, AUSTRIA, BELGIUM, BRAZIL, CANADA, CHILE, CHINA, COLOMBIA, CZECH REPUBLIC, DENMARK, EAU, EGYPT, FRANCE, GERMANY, GREECE, HUNGARY, INDIA, IRELAND, ISRAEL, ITALY, JAPAN, KENYA, MALAYSIA, MEXICO, MYANMAR, NETHERLANDS, NORWAY, OMAN, PAKISTAN, PORTUGAL, QATAR, SAUDI ARABIA, SINGAPORE, SLOVAKIA, SLOVENIA, SOUTH AFRICA, SOUTH KOREA, SPAIN, SWEDEN, SWITZERLAND, TAIWAN, THAILAND, TURKEY, UK, VIETNAM.
- How much
- US:245 (16 FlexLab systems, 121 Accelerator a3600 system, 108 Aptio Automation systems).
Vesmatic Cube 80 Interface Module (VMC)-Laboratory Automation system Brand names of the same product: FlexL
Z-1562-2023 · Class II · reported 2023-05-10 · Ongoing
- Why it was recalled
- Firmware versions have the potential to mis-associate sample IDs leading to incorrect results or delayed sodium, potassium, and chloride patient results. Falsely increased or decreased electrolytes can lead to either inappropriate treatment of normal results, or failure to treat abnormal results resulting in abnormal levels. Abnormal potassium levels can result in weakness, polyuria, ileus, psychiatric disturbances, cardiac arrhythmias, respiratory depression, and death. Abnormal sodium levels can result in CNS disturbances and disturbances of water balance. Abnormal chloride levels can lead to acid base disturbances which can lead to respiratory and cardiac compromise. The event may occur only if all the following conditions occurs in few milliseconds timeframe: - The module is releasing a sample tube (Tube A) just placed into the carrier - Another sample tube (Tube B) is erroneously not diverted into the module buffer lane due to a malfunction of the divert gate Only in this specific scenario, the Tube A may be released by the module as Tube B due to a miscommunication between the module firmware and the Automation software without any error message. The Automation...
- Product
- Vesmatic Cube 80 Interface Module (VMC)-Laboratory Automation system Brand names of the same product: FlexLab (FLX), Accelerator a3600 (ACP), Aptio Automation (AP2) Part Numbers: 72747000.A
- Where it went
- Worldwide distribution - US Nationwide and the countries of ARGENTINA, AUSTRALIA, AUSTRIA, BELGIUM, BRAZIL, CANADA, CHILE, CHINA, COLOMBIA, CZECH REPUBLIC, DENMARK, EAU, EGYPT, FRANCE, GERMANY, GREECE, HUNGARY, INDIA, IRELAND, ISRAEL, ITALY, JAPAN, KENYA, MALAYSIA, MEXICO, MYANMAR, NETHERLANDS, NORWAY, OMAN, PAKISTAN, PORTUGAL, QATAR, SAUDI ARABIA, SINGAPORE, SLOVAKIA, SLOVENIA, SOUTH AFRICA, SOUTH KOREA, SPAIN, SWEDEN, SWITZERLAND, TAIWAN, THAILAND, TURKEY, UK, VIETNAM.
- How much
- US: 245 (16 FlexLab systems, 121 Accelerator a3600 system, 108 Aptio Automation systems).
PVT Interface Module (PVT)-Laboratory Automation system Brand names of the same product: FlexLab (FLX), Acc
Z-1561-2023 · Class II · reported 2023-05-10 · Ongoing
- Why it was recalled
- Firmware versions have the potential to mis-associate sample IDs leading to incorrect results or delayed sodium, potassium, and chloride patient results. Falsely increased or decreased electrolytes can lead to either inappropriate treatment of normal results, or failure to treat abnormal results resulting in abnormal levels. Abnormal potassium levels can result in weakness, polyuria, ileus, psychiatric disturbances, cardiac arrhythmias, respiratory depression, and death. Abnormal sodium levels can result in CNS disturbances and disturbances of water balance. Abnormal chloride levels can lead to acid base disturbances which can lead to respiratory and cardiac compromise. The event may occur only if all the following conditions occurs in few milliseconds timeframe: - The module is releasing a sample tube (Tube A) just placed into the carrier - Another sample tube (Tube B) is erroneously not diverted into the module buffer lane due to a malfunction of the divert gate Only in this specific scenario, the Tube A may be released by the module as Tube B due to a miscommunication between the module firmware and the Automation software without any error message. The Automation...
- Product
- PVT Interface Module (PVT)-Laboratory Automation system Brand names of the same product: FlexLab (FLX), Accelerator a3600 (ACP), Aptio Automation (AP2) Part Numbers: 72747000.A
- Where it went
- Worldwide distribution - US Nationwide and the countries of ARGENTINA, AUSTRALIA, AUSTRIA, BELGIUM, BRAZIL, CANADA, CHILE, CHINA, COLOMBIA, CZECH REPUBLIC, DENMARK, EAU, EGYPT, FRANCE, GERMANY, GREECE, HUNGARY, INDIA, IRELAND, ISRAEL, ITALY, JAPAN, KENYA, MALAYSIA, MEXICO, MYANMAR, NETHERLANDS, NORWAY, OMAN, PAKISTAN, PORTUGAL, QATAR, SAUDI ARABIA, SINGAPORE, SLOVAKIA, SLOVENIA, SOUTH AFRICA, SOUTH KOREA, SPAIN, SWEDEN, SWITZERLAND, TAIWAN, THAILAND, TURKEY, UK, VIETNAM.
- How much
- US: 245 (16 FlexLab systems, 121 Accelerator a3600 system, 108 Aptio Automation systems).
Alinity h Interface Module (HSQ)-Laboratory Automation system Brand names of the same product: FlexLab (FLX
Z-1563-2023 · Class II · reported 2023-05-10 · Ongoing
- Why it was recalled
- Firmware versions have the potential to mis-associate sample IDs leading to incorrect results or delayed sodium, potassium, and chloride patient results. Falsely increased or decreased electrolytes can lead to either inappropriate treatment of normal results, or failure to treat abnormal results resulting in abnormal levels. Abnormal potassium levels can result in weakness, polyuria, ileus, psychiatric disturbances, cardiac arrhythmias, respiratory depression, and death. Abnormal sodium levels can result in CNS disturbances and disturbances of water balance. Abnormal chloride levels can lead to acid base disturbances which can lead to respiratory and cardiac compromise. The event may occur only if all the following conditions occurs in few milliseconds timeframe: - The module is releasing a sample tube (Tube A) just placed into the carrier - Another sample tube (Tube B) is erroneously not diverted into the module buffer lane due to a malfunction of the divert gate Only in this specific scenario, the Tube A may be released by the module as Tube B due to a miscommunication between the module firmware and the Automation software without any error message. The Automation...
- Product
- Alinity h Interface Module (HSQ)-Laboratory Automation system Brand names of the same product: FlexLab (FLX), Accelerator a3600 (ACP), Aptio Automation (AP2) Part Numbers: FLX-274-20
- Where it went
- Worldwide distribution - US Nationwide and the countries of ARGENTINA, AUSTRALIA, AUSTRIA, BELGIUM, BRAZIL, CANADA, CHILE, CHINA, COLOMBIA, CZECH REPUBLIC, DENMARK, EAU, EGYPT, FRANCE, GERMANY, GREECE, HUNGARY, INDIA, IRELAND, ISRAEL, ITALY, JAPAN, KENYA, MALAYSIA, MEXICO, MYANMAR, NETHERLANDS, NORWAY, OMAN, PAKISTAN, PORTUGAL, QATAR, SAUDI ARABIA, SINGAPORE, SLOVAKIA, SLOVENIA, SOUTH AFRICA, SOUTH KOREA, SPAIN, SWEDEN, SWITZERLAND, TAIWAN, THAILAND, TURKEY, UK, VIETNAM.
- How much
- US:245 (16 FlexLab systems, 121 Accelerator a3600 system, 108 Aptio Automation systems).
FlexLab (FLX), Accelerator a3600 (ACP), Aptio Automation (AP2). (Different brand names of same product.)
Z-0087-2022 · Class II · reported 2021-10-20 · Ongoing
- Why it was recalled
- The Firmware (FW) of the Automation System Interface Module to ADVIA Centaur XP/XPT may lead to an incorrect association of test results to sample ID. Improper management of the sample may bring an incorrect patient result.
- Product
- FlexLab (FLX), Accelerator a3600 (ACP), Aptio Automation (AP2). (Different brand names of same product.)
- Where it went
- Domestic distribution nationwide . Foreign distribution worldwide.
- How much
- 262 total, 52 US
Accelerator a3600 Automation System with the Aliquoter Module (Inpeco P/N FLX-212) The FlexLab (aka Accele
Z-0433-2021 · Class II · reported 2020-11-18 · Terminated
- Why it was recalled
- When a Clot Detection Error is generated during the sample aspiration from the Primary Sample Tube the aspirated volume is dispensed into the first empty Secondary Sample Tube. This Secondary Sample Tube is flagged with error 2132 or 1442 and sent to IOM Priority Output Racks to be manually managed. The current error message associated to error 2132 or 1442 recommends that the operator manages these Secondary Sample Tubes according to Laboratory Practice, but it does not clarify that these Secondary Sample Tubes may be diluted with water from the hydraulic circuit of the Aliquoter Module this may lead to reporting of erroneous results if the diluted sample is used for testing.
- Product
- Accelerator a3600 Automation System with the Aliquoter Module (Inpeco P/N FLX-212) The FlexLab (aka Accelerator a3600 and Aptio Automation) is a modular system designed to automate Pre-Analytical and Post-Analytical processing, sample handling in order to automate sample processing in the Laboratory. The systems consolidate multiple Analytical instruments into a unified workstation.
- Where it went
- Global Distribution including: USA and countries of: Algeria, Australia, Azerbaijan, Belgium, Brazil, Canada, Chile, China, Colombia, Croatia, Egypt, Finland, France, Germany, Indonesia, Israel, Italy, Libano, Mexico, Netherlands, Philippines, Portugal, Qatar, Saudi Arabia, Singapore, South Africa, Spain, Sweden, Switzerland, Taiwan, United Kingdom, and United Arab Emirates.
- How much
- 136
Aptio Automation System with the Aliquoter Module (Inpeco P/N FLX-212) The FlexLab (aka Accelerator a3600
Z-0434-2021 · Class II · reported 2020-11-18 · Terminated
- Why it was recalled
- When a Clot Detection Error is generated during the sample aspiration from the Primary Sample Tube the aspirated volume is dispensed into the first empty Secondary Sample Tube. This Secondary Sample Tube is flagged with error 2132 or 1442 and sent to IOM Priority Output Racks to be manually managed. The current error message associated to error 2132 or 1442 recommends that the operator manages these Secondary Sample Tubes according to Laboratory Practice, but it does not clarify that these Secondary Sample Tubes may be diluted with water from the hydraulic circuit of the Aliquoter Module this may lead to reporting of erroneous results if the diluted sample is used for testing.
- Product
- Aptio Automation System with the Aliquoter Module (Inpeco P/N FLX-212) The FlexLab (aka Accelerator a3600 and Aptio Automation) is a modular system designed to automate Pre-Analytical and Post-Analytical processing, sample handling in order to automate sample processing in the Laboratory. The systems consolidate multiple Analytical instruments into a unified workstation.
- Where it went
- Global Distribution including: USA and countries of: Algeria, Australia, Azerbaijan, Belgium, Brazil, Canada, Chile, China, Colombia, Croatia, Egypt, Finland, France, Germany, Indonesia, Israel, Italy, Libano, Mexico, Netherlands, Philippines, Portugal, Qatar, Saudi Arabia, Singapore, South Africa, Spain, Sweden, Switzerland, Taiwan, United Kingdom, and United Arab Emirates.
- How much
- 104
FlexLab (FLX) Automation System with the Aliquoter Module (Inpeco P/N FLX-212) The FlexLab (aka Accelerator
Z-0432-2021 · Class II · reported 2020-11-18 · Terminated
- Why it was recalled
- When a Clot Detection Error is generated during the sample aspiration from the Primary Sample Tube the aspirated volume is dispensed into the first empty Secondary Sample Tube. This Secondary Sample Tube is flagged with error 2132 or 1442 and sent to IOM Priority Output Racks to be manually managed. The current error message associated to error 2132 or 1442 recommends that the operator manages these Secondary Sample Tubes according to Laboratory Practice, but it does not clarify that these Secondary Sample Tubes may be diluted with water from the hydraulic circuit of the Aliquoter Module this may lead to reporting of erroneous results if the diluted sample is used for testing.
- Product
- FlexLab (FLX) Automation System with the Aliquoter Module (Inpeco P/N FLX-212) The FlexLab (aka Accelerator a3600 and Aptio Automation) is a modular system designed to automate Pre-Analytical and Post-Analytical processing, sample handling in order to automate sample processing in the Laboratory. The systems consolidate multiple Analytical instruments into a unified workstation.
- Where it went
- Global Distribution including: USA and countries of: Algeria, Australia, Azerbaijan, Belgium, Brazil, Canada, Chile, China, Colombia, Croatia, Egypt, Finland, France, Germany, Indonesia, Israel, Italy, Libano, Mexico, Netherlands, Philippines, Portugal, Qatar, Saudi Arabia, Singapore, South Africa, Spain, Sweden, Switzerland, Taiwan, United Kingdom, and United Arab Emirates.
- How much
- 93
Accelerator a3600 system with Sysmex XN-9000/XN-9100 Interface Module (dual robot) FLX-290-10; FLX-290-20 and
Z-2974-2020 · Class II · reported 2020-09-23 · Terminated
- Why it was recalled
- Firmware of the Sysmex XN-9000/XN-9100 Interface Module (IM) and of the Track to Rack Module has the potential to mis-associate sample IDs leading to incorrect results or delayed results
- Product
- Accelerator a3600 system with Sysmex XN-9000/XN-9100 Interface Module (dual robot) FLX-290-10; FLX-290-20 and Track to Rack Module FLX-295-10- Intended Clinical Chemistry Test Systems - Product Usage: The FlexLab 3.6 Automation is a modular system designed to automate Pre-Analytical and Post-Analytical processing, sample handling in order to automate sample processing in the Laboratory. The system consolidates analytical instruments, such as the ARCHITECT c8000 System into a unified workstation that perform a variety of instrument specific assays such as Sodium, Potassium and Chloride. Sodium, Potassium and Chloride measurements are used in the diagnosis and treatment of diseases involving electrolyte imbalance.
- Where it went
- Worldwide distribution - US Nationwide distribution including in the states of AK, FL, IA, LA, MA, MS, MT, NC, OH, TX, VA and the countries of AUSTRALIA, AUSTRIA, BELGIUM, DENMARK, FRANCE, GERMANY, ITALY, JAPAN, NETHERLANDS. NORWAY SAUDI ARABIA SOUTH KOREA SWEDEN UNITED ARAB EMIRATES
- How much
- 2 US and 6 OUS
Aptio Automation systems with Sysmex XN-9000/XN-9100 Interface Module (dual robot) FLX-290-10; FLX-290-20 and
Z-2975-2020 · Class II · reported 2020-09-23 · Terminated
- Why it was recalled
- Firmware of the Sysmex XN-9000/XN-9100 Interface Module (IM) and of the Track to Rack Module has the potential to mis-associate sample IDs leading to incorrect results or delayed results
- Product
- Aptio Automation systems with Sysmex XN-9000/XN-9100 Interface Module (dual robot) FLX-290-10; FLX-290-20 and Track to Rack Module FLX-295-10- Intended Clinical Chemistry Test Systems - Product Usage: The FlexLab 3.6 Automation is a modular system designed to automate Pre-Analytical and Post-Analytical processing, sample handling in order to automate sample processing in the Laboratory. The system consolidates analytical instruments, such as the ARCHITECT c8000 System into a unified workstation that perform a variety of instrument specific assays such as Sodium, Potassium and Chloride. Sodium, Potassium and Chloride measurements are used in the diagnosis and treatment of diseases involving electrolyte imbalance.
- Where it went
- Worldwide distribution - US Nationwide distribution including in the states of AK, FL, IA, LA, MA, MS, MT, NC, OH, TX, VA and the countries of AUSTRALIA, AUSTRIA, BELGIUM, DENMARK, FRANCE, GERMANY, ITALY, JAPAN, NETHERLANDS. NORWAY SAUDI ARABIA SOUTH KOREA SWEDEN UNITED ARAB EMIRATES
- How much
- 10 US and 22 OUS
FlexLab (FLX) with Sysmex XN-9000/XN-9100 Interface Module (dual robot) FLX-290-10; FLX-290-20 and Track to
Z-2973-2020 · Class II · reported 2020-09-23 · Terminated
- Why it was recalled
- Firmware of the Sysmex XN-9000/XN-9100 Interface Module (IM) and of the Track to Rack Module has the potential to mis-associate sample IDs leading to incorrect results or delayed results
- Product
- FlexLab (FLX) with Sysmex XN-9000/XN-9100 Interface Module (dual robot) FLX-290-10; FLX-290-20 and Track to Rack Module FLX-295-10- Intended Laboratory Automation system - Product Usage: The FlexLab 3.6 Automation is a modular system designed to automate Pre-Analytical and Post-Analytical processing, sample handling in order to automate sample processing in the Laboratory. The system consolidates analytical instruments, such as the ARCHITECT c8000 System into a unified workstation that perform a variety of instrument specific assays such as Sodium, Potassium and Chloride. Sodium, Potassium and Chloride measurements are used in the diagnosis and treatment of diseases involving electrolyte imbalance.
- Where it went
- Worldwide distribution - US Nationwide distribution including in the states of AK, FL, IA, LA, MA, MS, MT, NC, OH, TX, VA and the countries of AUSTRALIA, AUSTRIA, BELGIUM, DENMARK, FRANCE, GERMANY, ITALY, JAPAN, NETHERLANDS. NORWAY SAUDI ARABIA SOUTH KOREA SWEDEN UNITED ARAB EMIRATES
- How much
- 2 US and 6 OUS
Accelerator a3600 Automation System using the Aliquoter Module (Inpeco P/N FLX-212) - Product Usage: The syste
Z-2199-2020 · Class II · reported 2020-06-10 · Ongoing
- Why it was recalled
- In certain firmware versions, in case a Clot Detection error (error code E0E0 or 13E0) is generated during the sample aspiration the current error recovery procedure dispenses 2/3 of sample volume back into the Primary Tube. Evidence from the field showed that in case of Clot Detection error, this management may lead to the dilution of the Primary Tube with the distilled water of the hydraulic circuit of the Aliquoter Module.
- Product
- Accelerator a3600 Automation System using the Aliquoter Module (Inpeco P/N FLX-212) - Product Usage: The systems consolidate multiple Analytical instruments into a unified workstation.
- Where it went
- US Nationwide distribution including in the states of IL, NY.
- How much
- 97 systems
Aptio Automation System using the Aliquoter Module (Inpeco P/N FLX-212) - Product Usage: The systems consolida
Z-2200-2020 · Class II · reported 2020-06-10 · Ongoing
- Why it was recalled
- In certain firmware versions, in case a Clot Detection error (error code E0E0 or 13E0) is generated during the sample aspiration the current error recovery procedure dispenses 2/3 of sample volume back into the Primary Tube. Evidence from the field showed that in case of Clot Detection error, this management may lead to the dilution of the Primary Tube with the distilled water of the hydraulic circuit of the Aliquoter Module.
- Product
- Aptio Automation System using the Aliquoter Module (Inpeco P/N FLX-212) - Product Usage: The systems consolidate multiple Analytical instruments into a unified workstation.
- Where it went
- US Nationwide distribution including in the states of IL, NY.
- How much
- 61 systems
FlexLab Augomation System using the Aliquoter Module (Inpeco P/N FLX-212) The systems consolidate multiple Ana
Z-2198-2020 · Class II · reported 2020-06-10 · Ongoing
- Why it was recalled
- Potential for discrepant patient results due to a potential for the primary sample tube to be diluted. In certain firmware versions, in case a Clot Detection error (error code E0E0 or 13E0) is generated during the sample aspiration the current error recovery procedure dispenses 2/3 of sample volume back into the Primary Tube. Evidence from the field showed that in case of Clot Detection error, this management may lead to the dilution of the Primary Tube with the distilled water of the hydraulic circuit of the Aliquoter Module.
- Product
- FlexLab Augomation System using the Aliquoter Module (Inpeco P/N FLX-212) The systems consolidate multiple Analytical instruments into a unified workstation.
- Where it went
- US Nationwide distribution including in the states of IL, NY.
- How much
- 71 systems
Accelerator a3600 Automation System with Advia2120LAS Interface Module (P/N FLX-219-00, FLX-219-10), ImmunoCAP
Z-2141-2020 · Class II · reported 2020-06-03 · Terminated
- Why it was recalled
- The identified problem is an erroneous association between the carrier and the sample tube caused by a communication error between the firmware of the Interface Modules and the Automation software. This problem can occur only when one of these Interface Modules is put off-line after a carrier in their secondary lane is physically returned on the main track and then put back on-line when the carrier is used to transport another tube.
- Product
- Accelerator a3600 Automation System with Advia2120LAS Interface Module (P/N FLX-219-00, FLX-219-10), ImmunoCAP 1000 Interface Module (P/N FLX-226-01, FLX-226-10), or StaRRsed Interface Module (P/N FLX-268-00) is a modular system designed to automate Pre-Analytical and Post-Analytical processing, sample handling in order to automate sample processing in the Laboratory. The systems consolidate multiple Analytical instruments into a unified workstation.
- Where it went
- US Nationwide including in the states of IL, NY.
- How much
- 3 systems
FlexLab Automation System with Advia2120LAS Interface Module (P/N FLX-219-00, FLX-219-10), ImmunoCAP 1000 Inte
Z-2140-2020 · Class II · reported 2020-06-03 · Terminated
- Why it was recalled
- The identified problem is an erroneous association between the carrier and the sample tube caused by a communication error between the firmware of the Interface Modules and the Automation software. This problem can occur only when one of these Interface Modules is put off-line after a carrier in their secondary lane is physically returned on the main track and then put back on-line when the carrier is used to transport another tube.
- Product
- FlexLab Automation System with Advia2120LAS Interface Module (P/N FLX-219-00, FLX-219-10), ImmunoCAP 1000 Interface Module (P/N FLX-226-01, FLX-226-10), or StaRRsed Interface Module (P/N FLX-268-00)is a modular system designed to automate Pre-Analytical and Post-Analytical processing, sample handling in order to automate sample processing in the Laboratory. The systems consolidate multiple Analytical instruments into a unified workstation.
- Where it went
- US Nationwide including in the states of IL, NY.
- How much
- 37 systems
FlexLab Automation System used with the following Modules: High Volume Storage(P/N FLX-270, FLX-271, FLX-276,
Z-2114-2020 · Class II · reported 2020-06-03 · Terminated
- Why it was recalled
- The sensors which activate the safety switches may be affected by delayed activation. In 1% of the cases, the response delay can be up to a maximum delay of 2 seconds, instead of 40ms expected by design.
- Product
- FlexLab Automation System used with the following Modules: High Volume Storage(P/N FLX-270, FLX-271, FLX-276, FLX-282, FLX-283), HSQ Interface Module (P/N FLX-274), Aliquoter Module (P/N FLX-209), Rack Output Module ROM400 (P/N FLX-289), XN-9000 Interface Module (P/N FLX-290), Advia 2120 LAS Interface Module (P/N FLX-219), Vertical Transportation Module (P/N FLX -204), Rack Input Module (P/N FLX-214), AUWi System Interface Module (P/N FLX-286), Track To Rack Interface Module (P/N FLX-295) - Product Usage: is a modular system designed to automate Pre-Analytical and Post-Analytical processing, sample handling in order to automate sample processing in the Laboratory. The systems consolidate multiple Analytical instruments into a unified workstation.
- Where it went
- The products were distributed to the following US States: IL and NY.
- How much
- 10 systems
Accelerator a3600 Automation System used with the following Modules: High Volume Storage(P/N FLX-270, FLX-271,
Z-2115-2020 · Class II · reported 2020-06-03 · Terminated
- Why it was recalled
- The sensors which activate the safety switches may be affected by delayed activation. In 1% of the cases, the response delay can be up to a maximum delay of 2 seconds, instead of 40ms expected by design.
- Product
- Accelerator a3600 Automation System used with the following Modules: High Volume Storage(P/N FLX-270, FLX-271, FLX-276, FLX-282, FLX-283), HSQ Interface Module (P/N FLX-274), Aliquoter Module (P/N FLX-209), Rack Output Module ROM400 (P/N FLX-289), XN-9000 Interface Module (P/N FLX-290), Advia 2120 LAS Interface Module (P/N FLX-219), Vertical Transportation Module (P/N FLX -204), Rack Input Module (P/N FLX-214), AUWi System Interface Module (P/N FLX-286), Track To Rack Interface Module (P/N FLX-295) - Product Usage: is a modular system designed to automate Pre-Analytical and Post-Analytical processing, sample handling in order to automate sample processing in the Laboratory. The systems consolidate multiple Analytical instruments into a unified workstation.
- Where it went
- The products were distributed to the following US States: IL and NY.
- How much
- 2 systems
Aptio Automation System with Advia2120LAS Interface Module (P/N FLX-219-00, FLX-219-10), ImmunoCAP 1000 Interf
Z-2142-2020 · Class II · reported 2020-06-03 · Terminated
- Why it was recalled
- The identified problem is an erroneous association between the carrier and the sample tube caused by a communication error between the firmware of the Interface Modules and the Automation software. This problem can occur only when one of these Interface Modules is put off-line after a carrier in their secondary lane is physically returned on the main track and then put back on-line when the carrier is used to transport another tube.
- Product
- Aptio Automation System with Advia2120LAS Interface Module (P/N FLX-219-00, FLX-219-10), ImmunoCAP 1000 Interface Module (P/N FLX-226-01, FLX-226-10), or StaRRsed Interface Module (P/N FLX-268-00) - Product Usage: is a modular system designed to automate Pre-Analytical and Post-Analytical processing, sample handling in order to automate sample processing in the Laboratory. The systems consolidate multiple Analytical instruments into a unified workstation.
- Where it went
- US Nationwide including in the states of IL, NY.
- How much
- 70 systems
Inpeco FlexLab, ARCHITECT cSystem c8000/c16000 Interface Module, Part Numbers: FLX-208-00, FLX-208-10 - Produc
Z-2003-2020 · Class II · reported 2020-05-20 · Terminated
- Why it was recalled
- When analyzer sample carousel lid remains open or manual process is too long, Module timeout expiry errors could occur causing cross contamination of samples.
- Product
- Inpeco FlexLab, ARCHITECT cSystem c8000/c16000 Interface Module, Part Numbers: FLX-208-00, FLX-208-10 - Product Usage: The FlexLab (aka Accelerator a3600) is a modular system designed to automate Pre-Analytical and Post-Analytical processing, sample handling in order to automate sample processing in the Laboratory. The systems consolidate multiple Analytical instruments into a unified workstation.
- Where it went
- Worldwide distribution - US Nationwide including in the states of Texas, West Virginia, South Carolina, Delaware, Louisiana, Illinois, Georgia, Florida, New York, Virginia, Arkansas, Wisconsin, California, Minnesota, Missouri, North Carolina, Utah, Michigan, Ohio, Alabama, Oklahoma, Tennessee, Kansas, Hawaii, Arizona, Washington
- How much
- 82
Abbott Accelerator a3600, ARCHITECT cSystem c8000/c16000 Interface Module, Part Numbers: ACP-208-00 - Product
Z-2004-2020 · Class II · reported 2020-05-20 · Terminated
- Why it was recalled
- When analyzer sample carousel lid remains open or manual process is too long, Module timeout expiry errors could occur causing cross contamination of samples.
- Product
- Abbott Accelerator a3600, ARCHITECT cSystem c8000/c16000 Interface Module, Part Numbers: ACP-208-00 - Product Usage: The FlexLab (aka Accelerator a3600) is a modular system designed to automate Pre-Analytical and Post-Analytical processing, sample handling in order to automate sample processing in the Laboratory. The systems consolidate multiple Analytical instruments into a unified workstation.
- Where it went
- Worldwide distribution - US Nationwide including in the states of Texas, West Virginia, South Carolina, Delaware, Louisiana, Illinois, Georgia, Florida, New York, Virginia, Arkansas, Wisconsin, California, Minnesota, Missouri, North Carolina, Utah, Michigan, Ohio, Alabama, Oklahoma, Tennessee, Kansas, Hawaii, Arizona, Washington
- How much
- 273
Abbott Accelerator a3600 Centrifuge Module tube loading algorithm, Inpeco SA P/N: FLX-202, with Firmware Versi
Z-1888-2020 · Class II · reported 2020-05-13 · Ongoing
- Why it was recalled
- The FlexLab Centrifuge Module loading algorithm may lead to unbalanced loads which could damage the centrifuge.
- Product
- Abbott Accelerator a3600 Centrifuge Module tube loading algorithm, Inpeco SA P/N: FLX-202, with Firmware Versions: CM_1-7-0.H86 or xCMd_2-5-0.elf and CM_1-7-1.H86 or xCMd_2-5-1-849fad9.elf
- Where it went
- Worldwide distribution including the following states: Ohio, New York, Virginia, Pennsylvania, Texas, Delaware, California, Florida, Kentucky, Tennessee, Maryland, Rhode Island, Alabama, Massachusetts, Connecticut, Minnesota, Alabama, Montana, Louisiana, New Jersey, Virginia, New Hampshire, Michigan, North Carolina, Washington, Iowa, New Mexico, Nebraska, and Missouri
- How much
- 23 units
Siemens Aptio Automation Centrifuge Module, tube loading algorithm, Inpeco SA P/N: FLX-202, with Firmware Vers
Z-1889-2020 · Class II · reported 2020-05-13 · Ongoing
- Why it was recalled
- The FlexLab Centrifuge Module loading algorithm may lead to unbalanced loads which could damage the centrifuge.
- Product
- Siemens Aptio Automation Centrifuge Module, tube loading algorithm, Inpeco SA P/N: FLX-202, with Firmware Versions: CM_1-7-0.H86 or xCMd_2-5-0.elf and CM_1-7-1.H86 or xCMd_2-5-1-849fad9.elf
- Where it went
- Worldwide distribution including the following states: Ohio, New York, Virginia, Pennsylvania, Texas, Delaware, California, Florida, Kentucky, Tennessee, Maryland, Rhode Island, Alabama, Massachusetts, Connecticut, Minnesota, Alabama, Montana, Louisiana, New Jersey, Virginia, New Hampshire, Michigan, North Carolina, Washington, Iowa, New Mexico, Nebraska, and Missouri
- How much
- 313
Inpeco FlexLab Centrifuge Module tube loading algorithm, Inpeco SA P/N: FLX-202, with Firmware Versions: CM_1-
Z-1887-2020 · Class II · reported 2020-05-13 · Ongoing
- Why it was recalled
- The FlexLab Centrifuge Module loading algorithm may lead to unbalanced loads which could damage the centrifuge.
- Product
- Inpeco FlexLab Centrifuge Module tube loading algorithm, Inpeco SA P/N: FLX-202, with Firmware Versions: CM_1-7-0.H86 or xCMd_2-5-0.elf and CM_1-7-1.H86 or xCMd_2-5-1-849fad9.elf
- Where it went
- Worldwide distribution including the following states: Ohio, New York, Virginia, Pennsylvania, Texas, Delaware, California, Florida, Kentucky, Tennessee, Maryland, Rhode Island, Alabama, Massachusetts, Connecticut, Minnesota, Alabama, Montana, Louisiana, New Jersey, Virginia, New Hampshire, Michigan, North Carolina, Washington, Iowa, New Mexico, Nebraska, and Missouri
- How much
- 65 units
Showing the 30 most recent of 33. The rest are searchable at the FDA enforcement report database.
Read these counts with three things in mind
A firm with more recalls usually makes more products. A contract packer runs
hundreds of lines. It will out-recall a company with one product whatever either
does. This is not a safety ranking.
Most recalls here are voluntary. A firm found its own fault and pulled the stock.
That is the system working. It lands in this database looking the same as a recall
the FDA had to push for.
Terminated means the FDA considers the recall finished. It is not a verdict.
It does not mean anyone was harmed.
Source: openFDA enforcement reports, retrieved 2026-08-05. FDA dataset last updated 2026-07-29.
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