Tosoh Bioscience Inc: 74 FDA recall reports
Every medical device recall the FDA has published for Tosoh Bioscience Inc. The fault, and how the agency graded it.
74Reports
0Class I
1Ongoing
2026-07-22Most 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.
ST AIA-Pack Testosterone, IN VITRO DIAGNOSTIC USE ONLY for the quantitative measurement of testosterone in hum
Z-2746-2026 · Class II · reported 2026-07-22 · Ongoing
- Why it was recalled
- The Test cup lot F level 1 low-quality control results values for the device were lower than expected on the Automated Immunoassay Analyzer (AIA) which could cause falsely elevated or falsely low total testosterone results. Such erroneous test results may lead to additional testing/diagnostic interventions and in limited cases, may lead to a delay in diagnosis and/or initiation of unnecessary or incorrect clinical treatment measures.
- Product
- ST AIA-Pack Testosterone, IN VITRO DIAGNOSTIC USE ONLY for the quantitative measurement of testosterone in human serum on specific Tosoh AIA System analyzers, Model Number 0025204
- Where it went
- Global Distribution. US Nationwide.
- How much
- 310 units
Thyroglobulin Antibody (TgAB) Calibrator - Product Usage: intended for IN VITRO DIAGNOSTIC USE ONLY for the q
Z-1187-2021 · Class II · reported 2021-03-17 · Terminated
- Why it was recalled
- Some combinations of Calibrator lots and AlA PACKS resulted in Calibrator #6 not giving a value, making the calibration unacceptable.
- Product
- Thyroglobulin Antibody (TgAB) Calibrator - Product Usage: intended for IN VITRO DIAGNOSTIC USE ONLY for the quantitative measurement of anti-thyroglobulin antibodies (TgAb) in human serum on specific TOSOH AIA System analyzers. Measurements obtained by this device aid in the diagnosis of autoimmune thyroid disorders, such as Graves disease and Hashimotos disease. Comment to IU: Please note that the Calibrator set is not part of the IU but required for the assay.
- Where it went
- US Nationwide distribution in the states of CA, FL, GA, NY, OH & OR.
- How much
- 34 boxess/2 sets/6 bottles
Tosoh Bioscience AIA-PACK BHCG Calibration Verification Test Set-In Vitro Diagnostic for BHCG-pregnancy Part
Z-2968-2020 · Class II · reported 2020-09-23 · Terminated
- Why it was recalled
- Decreased stability for five (5) lots of Calibrator Sets and Calibration Verification Test Sets, resulting in a decrease measured concentration of HCG up to 20%.
- Product
- Tosoh Bioscience AIA-PACK BHCG Calibration Verification Test Set-In Vitro Diagnostic for BHCG-pregnancy Part number: 020661 The AIA-Pack BHCG Calibrator Set is intended for IN VITRO DIAGNOSTIC USE ONLY for the calibration of the ST AIA-PACK BHCG assay
- Where it went
- Worldwide Distribution: US (Nationwide) and countries of: Bogota, Cayman Islands, Mexico, Peru, and San Salvador.
- How much
- 39 boxes
Tosoh Bioscience AIA- PACK HCG Calibrator Set-In Vitro Diagnostic for BHCG Part number 020361 The AIA-Pack
Z-2967-2020 · Class II · reported 2020-09-23 · Terminated
- Why it was recalled
- Decreased stability for five (5) lots of Calibrator Sets and Calibration Verification Test Sets, resulting in a decrease measured concentration of HCG up to 20%.
- Product
- Tosoh Bioscience AIA- PACK HCG Calibrator Set-In Vitro Diagnostic for BHCG Part number 020361 The AIA-Pack BHCG Calibrator Set is intended for IN VITRO DIAGNOSTIC USE ONLY for the calibration of the ST AIA-PACK BHCG assay
- Where it went
- Worldwide Distribution: US (Nationwide) and countries of: Bogota, Cayman Islands, Mexico, Peru, and San Salvador.
- How much
- 289 boxes
AIA-900 Analyzer, Part no. 022930, UDI 04560189283992
Z-2423-2020 · Class II · reported 2020-07-01 · Terminated
- Why it was recalled
- The Substrate Monitoring System in the AIA-900 Analyzer did not detect an empty substrate bottle. The issue may lead to erroneous immunoassay test results.
- Product
- AIA-900 Analyzer, Part no. 022930, UDI 04560189283992
- Where it went
- Domestic distribution nationwide. Foreign distribution to Chile, Costa Rica, Cayman Islands, Dominican Republic, Ecuador, Guatemala, Honduras, Peru, Republic of Panama, El Salvador, and Uruguay.
- How much
- 529
AIA-360 Automated Immunoassay Analyzer, Product Code 019945
Z-1420-2020 · Class II · reported 2020-03-11 · Terminated
- Why it was recalled
- A display screen software issue on the analyzer causes the display to freeze when display screen is touched at the same time as a command from the instrument firmware, causing the instrument to stop. As a result, the run is aborted and the results are not retrievable.
- Product
- AIA-360 Automated Immunoassay Analyzer, Product Code 019945
- Where it went
- Distributed to AZ, NE, NJ, NY, and WA. Foreign distribution to Cayman Islands, Costa Rica, and Uruguay
- How much
- 12
ST AIA-PACK ACTH (ACTH: Adrenocorticotropic Hormone) is designed for IN VITRO DIAGNOSTIC USE ONLY for the quan
Z-0676-2019 · Class II · reported 2019-01-02 · Terminated
- Product
- ST AIA-PACK ACTH (ACTH: Adrenocorticotropic Hormone) is designed for IN VITRO DIAGNOSTIC USE ONLY for the quantitative measurement of Adrenocorticotropic hormone (ACTH) in human EDT A plasma. Measurements of ACTH are used in the differential diagnosis and treatment of certain disorders of the adrenal glands such as Cushing's syndrome, adrenocortical insufficiency and the ectopic ACTH syndrome.
- Where it went
- US Nationwide
- How much
- 1085 units
AIA-PACK Folate (FOL) is designed for IN VITRO DIAGNOSTIC USE ONLY for the quantitative measurement of folate
Z-0672-2019 · Class II · reported 2019-01-02 · Terminated
- Product
- AIA-PACK Folate (FOL) is designed for IN VITRO DIAGNOSTIC USE ONLY for the quantitative measurement of folate in human serum on Tosoh AIA System analyzers.
- Where it went
- US Nationwide
- How much
- 19366 units
ST AIA-PACK Homocysteine (HCY) is designed for IN VITRO DIAGNOSTIC USE ONLY for the quantitative measurement o
Z-0675-2019 · Class II · reported 2019-01-02 · Terminated
- Product
- ST AIA-PACK Homocysteine (HCY) is designed for IN VITRO DIAGNOSTIC USE ONLY for the quantitative measurement of homocysteine in human serum, heparinized plasma or EDT A plasma on TOSOH AIA System Analyzers. Homocysteine measurements are used in the diagnosis and treatment of hyperhomocysteinemia or homocysteinuria.
- Where it went
- US Nationwide
- How much
- 992 units
ST AIA-PACK Testosterone (TES) is designed for IN VITRO DIAGNOSTIC USE ONLY for the quantitative measurement o
Z-0674-2019 · Class II · reported 2019-01-02 · Terminated
- Product
- ST AIA-PACK Testosterone (TES) is designed for IN VITRO DIAGNOSTIC USE ONLY for the quantitative measurement of testosterone in human serum on specific Tosoh AIA System analyzers. Measurement of testosterone is used to aid in the diagnosis and management of conditions involving excess or deficiency of this androgen.
- Where it went
- US Nationwide
- How much
- 26745 units
ST AIA-PACK FT3 (FT3: Free Triiodothyronine) is designed for IN VITRO DIAGNOSTIC USE ONLY for the quantitative
Z-0673-2019 · Class II · reported 2019-01-02 · Terminated
- Product
- ST AIA-PACK FT3 (FT3: Free Triiodothyronine) is designed for IN VITRO DIAGNOSTIC USE ONLY for the quantitative measurement of Free Triiodothyronine (FT3) in human serum or heparinized plasma on specific Tosoh AIA System analyzers.
- Where it went
- US Nationwide
- How much
- 24083 units
AIA-PACK B12 (Vitamin B12) is designed for IN VITRO DIAGNOSTIC USE ONLY for the quantitative measurement of vi
Z-0671-2019 · Class II · reported 2019-01-02 · Terminated
- Why it was recalled
- Potential for fluorescein interference to cause inaccurately elevated results for certain Tosoh AIA assays
- Product
- AIA-PACK B12 (Vitamin B12) is designed for IN VITRO DIAGNOSTIC USE ONLY for the quantitative measurement of vitamin B12 (B12) in human serum on Tosoh AIA System analyzers.
- Where it went
- US Nationwide
- How much
- 29645 units
AIA-360 Analyzer is capable of performing two methods of immunoassay: an immunoenzymetric (IEMA) or sandwich i
Z-0613-2019 · Class II · reported 2018-12-26 · Terminated
- Why it was recalled
- The firm has become aware of a potential issue with the AIA-360 analyzer that could prevent the table home sensor from detecting the table home position. If the malfunction with the table home sensor occurs on the AIA-360, the sensor board may need to be replaced. If the home sensor fails to detect the home position, the AIA-360 analyzer will cease to function and will be unavailable for use. If this issue occurs, there may be a delay in testing and reporting patient test results. Tosoh has received three (3) complaints related to this issue with no serious injuries reported.
- Product
- AIA-360 Analyzer is capable of performing two methods of immunoassay: an immunoenzymetric (IEMA) or sandwich immunoassay, a competitive binding (EIA) immunoassay. An antigen-antibody reaction begins by combining a patient sample, control, or calibrator with a diluent in an immunoreaction test cup from the AIA-PACK reagent series.
- Where it went
- Nationwide distribution. International distribution to Honduras, Caribbean, Chile, Colombia, Costa Rica, Uruguay, Ecuador, Panama, Mexico, Canada, and Venezuela.
- How much
- 438
Hemoglobin A1c Control, Part no. 220232 for use as quality control material to monitor the precision of labora
Z-0601-2019 · Class III · reported 2018-12-19 · Terminated
- Why it was recalled
- Tosoh Bioscience has become aware of potential degradation of HbA1c control lot # 7055 before the 60-days product stability claim. If degradation of these controls occurs, P00 peaks may be seen and the % HbA1c control values may drift higher than the assigned range. This may result in delays when performing routine instrument quality control. If this issue occurs, there may be a delay in testing and reporting patient test results. Tosoh has received two (2) complaints related to this issue with no serious injuries reported.
- Product
- Hemoglobin A1c Control, Part no. 220232 for use as quality control material to monitor the precision of laboratory testing procedures for HbA1c quantitation.
- Where it went
- Distributed nationwide. Foreign distribution to Canada.
- How much
- 1000
AIA-2000 Analyzer, Product code 022100, 022100R, 022101, 022101R The AIA-2000 analyzer and AIA-900 analyze
Z-0599-2019 · Class II · reported 2018-12-19 · Terminated
- Why it was recalled
- Tosoh Bioscience has become aware of a potential issue with the AIA-900 and AIA-2000 analyzers that could result in slippage of the incubator unit contained within the system. If the tension of the timing belt is not adjusted correctly, it is possible for a misalignment that will result in a mechanical error. Tosoh has taken the required actions to inspect the tension of the timing belt during preventative maintenance and correct the instruments where this issue has been observed. If incubator slippage occurs, the unit will cease to function, and a system error will be reported. If this occurs, there may be a delay in testing and reporting patient test results. There have been no reports of injury related to this issue.
- Product
- AIA-2000 Analyzer, Product code 022100, 022100R, 022101, 022101R The AIA-2000 analyzer and AIA-900 analyzer are capable of performing three methods of immunoassay: an immunoenzymetric (IEMA) or sandwich immunoassay, a competitive binding (EIA) immunoassay, and a two-step immunoenzymetric immunoassay.
- Where it went
- US Nationwide distribution and International distribution to Colombia, Chile, Honduras, Cayman Islands, Panama, Costa Rica, Guatemala, Venezuela, Uruguay, Peru, and Ecuador.
- How much
- 95
AIA-900Analyzer, Product code 022930, 022930R The AIA-2000 analyzer and AIA-900 analyzer are capable of per
Z-0600-2019 · Class II · reported 2018-12-19 · Terminated
- Why it was recalled
- Tosoh Bioscience has become aware of a potential issue with the AIA-900 and AIA-2000 analyzers that could result in slippage of the incubator unit contained within the system. If the tension of the timing belt is not adjusted correctly, it is possible for a misalignment that will result in a mechanical error. Tosoh has taken the required actions to inspect the tension of the timing belt during preventative maintenance and correct the instruments where this issue has been observed. If incubator slippage occurs, the unit will cease to function, and a system error will be reported. If this occurs, there may be a delay in testing and reporting patient test results. There have been no reports of injury related to this issue.
- Product
- AIA-900Analyzer, Product code 022930, 022930R The AIA-2000 analyzer and AIA-900 analyzer are capable of performing three methods of immunoassay: an immunoenzymetric (IEMA) or sandwich immunoassay, a competitive binding (EIA) immunoassay, and a two-step immunoenzymetric immunoassay.
- Where it went
- US Nationwide distribution and International distribution to Colombia, Chile, Honduras, Cayman Islands, Panama, Costa Rica, Guatemala, Venezuela, Uruguay, Peru, and Ecuador.
- How much
- 395
AIA-900 Automated Immunoassay Analyzer performs three methods of immunoassay: an immunoenzymetric (IEMA) or s
Z-0602-2019 · Class II · reported 2018-12-19 · Terminated
- Why it was recalled
- The firm has become aware of a potential issue that may affect the mixing motor drive harness and mixing home detection sensor relay harness on your AIA-900 Analyzer. It is possible that the harnesses could rub against the Plarail chain during operation and result in premature wear. If observed, this issue will cause the following system error to be reported D.lane Mix home overrun error [4093] . If observed, this issue will cause the AIA-900 Analyzer not to function and the D.lane Mix home overrun error [4093] will be reported by the system. Replacement of the motor drive harness and mixing home detection sensor relay harness will mitigate the potential for premature wear and effectively prevent this issue from causing the system error. If the sensor relay harness fails, the AIA-900 analyzer will cease to function and will be unavailable for use. If this issue occurs, there may be a delay in testing and reporting patient test results. Tosoh is aware of two complaints associated with the unexpected wearing of the harness. There have been no user or patient injuries reported that are related to this device malfunction.
- Product
- AIA-900 Automated Immunoassay Analyzer performs three methods of immunoassay: an immunoenzymetric (IEMA) or sandwich immunoassay, a competitive binding (EIA) immunoassay, and a two-step immunoenzymetric immunoassay.
- Where it went
- Nationwide distribution. Foreign distribution to Chile, Colombia, Ecuador, Guatemala, Honduras, Panama, Peru, Puerto Rico, Uruguay, and Venezuela.
- How much
- 258
AIA-360 Analyzer, product code 019945/019945R The Tosoh AIA-360 Automated Immunoassay Analyzer is for use
Z-0559-2019 · Class II · reported 2018-12-12 · Terminated
- Why it was recalled
- The firm has implemented new product labeling changes for the Tosoh AIA-360 Analyzer. These labeling changes affect the Tosoh Quick Reference Guide, Training Manual and Training DVD previously provided by Tosoh Bioscience. These changes are being made to align the Tosoh Quick Reference Guide and associated training materials to the Operators Manual and provide clarification to the requirement that the maintenance of the B/F probe is to be performed by Tosoh a field service representative, the requirement for use of 70% Ethanol during daily shutdown procedures and the requirement for use of CAP Class 1 reagent grade water for dilution of the concentrated wash and diluent solutions and reconstitution of lyophilized reagents. Failure to follow these requirements may negatively affect system performance, lead to corrosion of instrument components over time, or result in bacterial contamination, respectively.
- Product
- AIA-360 Analyzer, product code 019945/019945R The Tosoh AIA-360 Automated Immunoassay Analyzer is for use in vitro diagnostic to provide testing for a broad menu of assays in a unique patented dry reagent format.
- Where it went
- Worldwide Distribution: US (Nationwide) and countries of: Mexico, Canada, Colombia, Chile, Venezuela, Ecuador, Uruguay, Peru, and Honduras.
- How much
- 1228
AIA-900 Automated Immunoassay Analyzer, product code 022930 /022930R Product Usage: The AIA-900 is capable
Z-0509-2019 · Class II · reported 2018-12-05 · Terminated
- Why it was recalled
- Tosoh Bioscience has become aware of a potential issue with the axis base of the turntable rotation drive motor on the AIA-900 Analyzer. If the tension of the timing belt between the turntable rotation pulley and drive motor is not adjusted correctly, it is possible to increase the lateral load on the motor axis resulting in the inclination and damage of the motor axis. Since January 12, 2017, Tosoh has been inspecting the tension of the timing belt during scheduled preventative maintenance visit and correcting the analyzers where this issue has been observed. If the drive motor fails, the AIA-900 analyzer will cease to function and will be unavailable for use. If this issue occurs, there may be a delay in testing and reporting patient test results. Tosoh has received five (5) complaints related to this issue with no serious injuries reported.
- Product
- AIA-900 Automated Immunoassay Analyzer, product code 022930 /022930R Product Usage: The AIA-900 is capable of performing three methods of immunoassay: an immunoenzymetric (IEMA) or sandwich immunoassay, a competitive binding (EIA) immunoassay, and a two-step immunoenzymetric immunoassay. An antigen-antibody reaction begins by combining a patient sample, control, or calibrator with a diluent in an immunoreaction test cup from the AIA-PACK reagent series.
- Where it went
- Worldwide Distribution - US Nationwide in the states of FL, MD, NV, NY, SC, and TX. and Foreign distribution to Cayman Islands, Chile, Columbia, Dominican Republic, Ecuador, Guatemala, Honduras, Peru, Puerto Rico, Uruguay, and Venezuela.
- How much
- 247
AIA-2000 Analyzer, Model Nos. AIA-2000LA, AIA-2000ST - Product Usage: The AIA-2000 is capable of performing t
Z-0475-2019 · Class II · reported 2018-11-28 · Terminated
- Why it was recalled
- There is a possibility that the liquid suction pump on some AIA-2000 analyzers may not perform as intended and cause an insufficient volume of wash solution to be removed during the washing step. Incomplete washing of the sample may result in falsely elevated test results for the sandwich assays and falsely decreased test results for the competitive binding assays. Insufficient washing is detectable through review of the calibration data and QC trending. For example, if incomplete washing occurs, the reported values for the zero- calibration rate will be above the acceptance range. The calibration value may shift and the instrument will not calibrate successfully. If this issue occurs, there may be a delay in testing and reporting patient test results. There have been no user or patient injuries reported related to this issue.
- Product
- AIA-2000 Analyzer, Model Nos. AIA-2000LA, AIA-2000ST - Product Usage: The AIA-2000 is capable of performing three methods of immunoassay: an immunoenzymetric (IEMA) or sandwich immunoassay, a competitive binding (EIA) immunoassay, and a two-step immunoenzymetric immunoassay. An antigen-antibody reaction begins by combining a patient sample, control, or calibrator with a diluent in an immunoreaction test cup from the AIA-PACK reagent series.
- Where it went
- US Nationwide distribution in the states of Florida, Kentucky, Maryland, Ohio, Pennsylvania, and Texas.
- How much
- 7
Tosoh AIA-900 immunoassay Analyzer
Z-0485-2019 · Class II · reported 2018-11-28 · Terminated
- Why it was recalled
- A software issue may cause the liquid volume detection entries for 2nd and 3rd reagent bottles to be overwritten with the data from the 1st reagent bottle. Tosoh has released software version 2.51 (or later) to fix the problem. This failure is mitigated by the hardware design. The consequence would be a slight delay in testing patient sample or reporting patient result.
- Product
- Tosoh AIA-900 immunoassay Analyzer
- Where it went
- Distributed to accounts in GA and NY.
- How much
- 3
AIA-900 Analyzer, Product code 022930, 022930R
Z-0469-2019 · Class II · reported 2018-11-21 · Terminated
- Why it was recalled
- Tosoh Bioscience has become aware of a potential issue with the pickup arm and pickup arm motor on the AIA-900 Analyzer. If the pickup arm or pickup arm motor malfunctions, the analyzer will cease to function and result in an inability to test patient samples. This may cause a delay in testing and reporting patient results. Tosoh has received fifty-one (51) complaints related to this issue with no serious injuries reported.
- Product
- AIA-900 Analyzer, Product code 022930, 022930R
- Where it went
- Distributed nationwide. Foreign distribution to Canada and Latin America.
- How much
- 393
G8 Automated HPLC Analyzer - 723G8 Product Usage - In vitro diagnostic use for the quantitative measurement
Z-3244-2018 · Class II · reported 2018-10-03 · Terminated
- Why it was recalled
- Analyzers were distributed with software which lacks a 510K
- Product
- G8 Automated HPLC Analyzer - 723G8 Product Usage - In vitro diagnostic use for the quantitative measurement of % hemoglobin A1c in whole blood specimens. This test is to be used as an aid in the diagnosis of diabetes and as an aid in identifying patients who may be at risk for developing diabetes.
- Where it went
- US Nationwide Distribution in states of - CA, OK, VA 7 WI
- How much
- 8 units
Tosoh Bioscience AIA Analyte Application Manual (AAM) CD Part Number: 997027 CD contains analyte applicati
Z-2827-2018 · Class III · reported 2018-08-22 · Terminated
- Why it was recalled
- Distribution of unapproved product labeling
- Product
- Tosoh Bioscience AIA Analyte Application Manual (AAM) CD Part Number: 997027 CD contains analyte application manuals for 47 analyte reagent packs for use with the Tosoh AIA (Automated Immuno-Assay) family of analyzers. Each analyte application manual includes a reference section on assay controls in the analyte application manual.
- Where it went
- US Distribution to states of: FL, MA, MT, OK, OR and WI.
- How much
- 9 CDS
G8 Automated HPLC Analyzer: HLC-723G8-ST, 021560; and HLC-723G8-LA, 021674 Product Usage: The Tosoh Automa
Z-2745-2018 · Class II · reported 2018-08-22 · Terminated
- Why it was recalled
- HbAE is known to interfere with the HbA1c assay on the current version of software, Ver. 5.23. Customers should exercise caution when reviewing chromatograms and ensure that Flag 43 is enabled on their device to avoid reporting invalid test results in the presence of HbAE.
- Product
- G8 Automated HPLC Analyzer: HLC-723G8-ST, 021560; and HLC-723G8-LA, 021674 Product Usage: The Tosoh Automated Glycohemoglobin Analyzer HLC-723G8 is intended for in vitro diagnostic use for the quantitative measurement of % hemoglobin A1c (HbA1c) (DCCT/NGSP) and mmol/mol hemoglobin A1c (IFCC) in whole blood specimens. This test is to be used as an aid in diagnosis of diabetes and as an aid in identifying patients who may be at risk for developing diabetes.
- Where it went
- Worldwide Distributed - US Nationwide. and the countries of Foreign distribution to Brazil, Caribbean, Chile, Colombia, Costa Rica, Dominican Republic, Ecuador, Panama, Peru, and Uruguay.
- How much
- 665
ST-AIA PACK Testosterone; Part Number: 025204 Assay, Reproductive Hormone
Z-2093-2018 · Class II · reported 2018-06-13 · Terminated
- Why it was recalled
- Asfotase Alfa (Strensiq) interferes with certain Tosoh assays which potentially causes falsely increased or falsely decreased immunoassay test results, depending upon the assay.
- Product
- ST-AIA PACK Testosterone; Part Number: 025204 Assay, Reproductive Hormone
- Where it went
- Worldwide Distribution: US (Nationwide) and countries of; Canada, Mexico, Columbia, Chile, Uruguay, Nicaragua, Argentina, Peru, Chile, Honduras. Equador, Caymen Islands, Panama, and Costa Rica.
- How much
- 10913
ST-AIA PACK Cort; Part Number: 025287 Assay, Metabolic
Z-2094-2018 · Class II · reported 2018-06-13 · Terminated
- Why it was recalled
- Asfotase Alfa (Strensiq) interferes with certain Tosoh assays which potentially causes falsely increased or falsely decreased immunoassay test results, depending upon the assay.
- Product
- ST-AIA PACK Cort; Part Number: 025287 Assay, Metabolic
- Where it went
- Worldwide Distribution: US (Nationwide) and countries of; Canada, Mexico, Columbia, Chile, Uruguay, Nicaragua, Argentina, Peru, Chile, Honduras. Equador, Caymen Islands, Panama, and Costa Rica.
- How much
- 4027
ST-AIA PACK Prolactin; Part Number: 025255 Assay, Reproductive Hormone
Z-2087-2018 · Class II · reported 2018-06-13 · Terminated
- Why it was recalled
- Asfotase Alfa (Strensiq) interferes with certain Tosoh assays which potentially causes falsely increased or falsely decreased immunoassay test results, depending upon the assay.
- Product
- ST-AIA PACK Prolactin; Part Number: 025255 Assay, Reproductive Hormone
- Where it went
- Worldwide Distribution: US (Nationwide) and countries of; Canada, Mexico, Columbia, Chile, Uruguay, Nicaragua, Argentina, Peru, Chile, Honduras. Equador, Caymen Islands, Panama, and Costa Rica.
- How much
- 4867
ST-AIA PACK CA 19-9; Part Number: 025271 Assay, Tumor Marker
Z-2069-2018 · Class II · reported 2018-06-13 · Terminated
- Why it was recalled
- Asfotase Alfa (Strensiq) interferes with certain Tosoh assays which potentially causes falsely increased or falsely decreased immunoassay test results, depending upon the assay.
- Product
- ST-AIA PACK CA 19-9; Part Number: 025271 Assay, Tumor Marker
- Where it went
- Worldwide Distribution: US (Nationwide) and countries of; Canada, Mexico, Columbia, Chile, Uruguay, Nicaragua, Argentina, Peru, Chile, Honduras. Equador, Caymen Islands, Panama, and Costa Rica.
- How much
- 4824
ST-AIA PACK Fer; Part Number: 025253 Assay, Anemia
Z-2096-2018 · Class II · reported 2018-06-13 · Terminated
- Why it was recalled
- Asfotase Alfa (Strensiq) interferes with certain Tosoh assays which potentially causes falsely increased or falsely decreased immunoassay test results, depending upon the assay.
- Product
- ST-AIA PACK Fer; Part Number: 025253 Assay, Anemia
- Where it went
- Worldwide Distribution: US (Nationwide) and countries of; Canada, Mexico, Columbia, Chile, Uruguay, Nicaragua, Argentina, Peru, Chile, Honduras. Equador, Caymen Islands, Panama, and Costa Rica.
- How much
- 24410
Showing the 30 most recent of 74. 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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