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Roche Molecular Systems, Inc.
Roche Molecular Systems, Inc.: 42 FDA recall reports
Every medical device recall the FDA has published for Roche Molecular Systems, Inc.. The fault, and how the agency graded it.
42Reports
0Class I
7Ongoing
2023-02-15Most 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.
cobas SARS-CoV-2 & Influenza A/B Qualitative nucleic acid test for use on the cobas 5800/6800/8800 Systems; Ma
Z-1105-2023 · Class II · reported 2023-02-15 · Ongoing
- Why it was recalled
- The firm received customer complaints regarding false negative Influenza A (Flu A) results and late Flu A Target Ct values. A false negative influenza A result may lead to additional testing, psychological distress, and delays to targeted therapy for influenza as well as true diagnosis.
- Product
- cobas SARS-CoV-2 & Influenza A/B Qualitative nucleic acid test for use on the cobas 5800/6800/8800 Systems; Material Number 09446125190
- Where it went
- Domestic distribution nationwide. Foreign distribution worldwide.
- How much
- 9,948 OUS only
cobas Influenza A/B & RSV UC (Utility Channel) Qualitative nucleic acid test for use on the cobas 6800/8800 Sy
Z-1106-2023 · Class II · reported 2023-02-15 · Ongoing
- Why it was recalled
- The firm received customer complaints regarding false negative Influenza A (Flu A) results and late Flu A Target Ct values. A false negative influenza A result may lead to additional testing, psychological distress, and delays to targeted therapy for influenza as well as true diagnosis.
- Product
- cobas Influenza A/B & RSV UC (Utility Channel) Qualitative nucleic acid test for use on the cobas 6800/8800 Systems; Material number 09233962190
- Where it went
- Domestic distribution nationwide. Foreign distribution worldwide.
- How much
- 727 kits OUS only
cobas SARS-CoV-2 & Influenza A/B Qualitative assay for use on the cobas 6800/8800 Systems; Material number 092
Z-1104-2023 · Class II · reported 2023-02-15 · Ongoing
- Why it was recalled
- The firm received customer complaints regarding false negative Influenza A (Flu A) results and late Flu A Target Ct values. A false negative influenza A result may lead to additional testing, psychological distress, and delays to targeted therapy for influenza as well as true diagnosis.
- Product
- cobas SARS-CoV-2 & Influenza A/B Qualitative assay for use on the cobas 6800/8800 Systems; Material number 09233474190
- Where it went
- Domestic distribution nationwide. Foreign distribution worldwide.
- How much
- 18,071 kits (US); 30,085 kits (OUS)
cobas 5800 instrument, Material No. 08707464001. Used for automated Polymerase Chain Reaction (PCR) based Nucl
Z-0097-2023 · Class II · reported 2022-10-26 · Terminated
- Why it was recalled
- Reported false positive and invalid results on the affected devices due to anomalous baselines. This may lead to erroneous or delayed diagnoses.
- Product
- cobas 5800 instrument, Material No. 08707464001. Used for automated Polymerase Chain Reaction (PCR) based Nucleic Acid Testing (NAT) in laboratory settings.
- Where it went
- International distribution in the countries of Austria, Belgium, Czech Republic, France, Germany, Greece, Ireland, Italy, Lithuania, Poland, Portugal, Spain, Sweden, Switzerland, UK, Chile, Colombia, Hong Kong, Jamaica, Japan, Nicaragua, Oman, Pakistan, UAE.
- How much
- 179 OUS
cobas LiatSystem, respiratory virus panel nucleic acid assay system, Material Number 07341920190
Z-0828-2022 · Class II · reported 2022-04-06 · Ongoing
- Why it was recalled
- Roche has identified a small number of cobas Liat analyzer units that have consistently high noise levels (background signal) originating from the amber detector (used for Influenza B detection). This noise increases the probability of false positive Influenza B results.
- Product
- cobas LiatSystem, respiratory virus panel nucleic acid assay system, Material Number 07341920190
- Where it went
- Worldwide distribution - US Nationwide distribution in the states of CO, IL, IN, KY, MI, NC, and TX. The countries of Cyprus, Spain, and Hong Kong.
- How much
- 14 units
cobas EGFR Mutation Test v2-Somatic gene mutation detection system Catalog Number :07248563190
Z-0083-2022 · Class II · reported 2021-10-20 · Ongoing
- Why it was recalled
- False Mutation Detected results for the exon 20 insertion (Ex20Ins) mutation when using the cobas EGFR Mutation Test v2, may lead to inappropriate treatment
- Product
- cobas EGFR Mutation Test v2-Somatic gene mutation detection system Catalog Number :07248563190
- Where it went
- Worldwide distribution - US Nationwide distribution and the countries of Canada, UK, Poland, Spain, Italy, Sweden, Greece, Denmark, Norway, Netherlands, France, Czech Republic, Belgium, Austria, Slovakia, Hungary, Switzerland, Lithuania, Slovenia. Serbia, North Macedonia, Myanmar, Lebanon, Russia, Croatia, Morocco, Kazakhstan, Dominican Republic, Israel, El Salvador, Vietnam, Malaysia, Taiwan, China, Japan, Hong Kong, Korea, Brazil, Philippines, Thailand, Chile, Colombia, Singapore, Argentina, Australia, India, Uruguay, Ecuador, Panama, Costa Rica, Pakistan, Peru, Indonesia, New Zealand.
- How much
- 507 US; 6,676 ex- US
cobas SARS-CoV-2 & Influenza A/B Test for use on the cobas Liat System, Catalog Number 09211101190
Z-2498-2021 · Class II · reported 2021-09-29 · Terminated
- Why it was recalled
- Customers have reported an increased number of false positive SARS-CoV-2 results.
- Product
- cobas SARS-CoV-2 & Influenza A/B Test for use on the cobas Liat System, Catalog Number 09211101190
- Where it went
- Worldwide distribution - US Nationwide distribution in the states of AR, CA, IL, IN, KS, ME, MI, MN, MO, NY, OR, TN, TX, WA, and WI. The countries of Canada, UK, Austria, Belgium, Croatia, Denmark, Finland, France, Germany, Netherlands, Norway, Poland, Slovakia, and Spain.
- How much
- 211 kits (US); 3073 kits (OUS)
cobas Liat Analyzer: respiratory virus panel nucleic acid assay system Catalog Number: 07341920190
Z-1414-2021 · Class II · reported 2021-04-21 · Ongoing
- Why it was recalled
- Invalid or false positive results for one or more targets (SARS-CoV-2/Influenza A/Influenza B) using the cobas SARS-CoV-2 & Influenza A/B assay for use under emergency use authorization on the cobas Liat analyzer, showed abnormal PCR growth curves
- Product
- cobas Liat Analyzer: respiratory virus panel nucleic acid assay system Catalog Number: 07341920190
- Where it went
- Nationwide WorldWide
- How much
- US: 5,430 units ; OUS 1528 units
cobas SARS-CoV-2 & Influenza A/B assay cobas Liat- Reagents, 2019-Novel Coronavirus Nucleic Acid for use on th
Z-1413-2021 · Class II · reported 2021-04-21 · Ongoing
- Why it was recalled
- Invalid or false positive results for one or more targets (SARS-CoV-2/Influenza A/Influenza B) using the cobas SARS-CoV-2 & Influenza A/B assay for use under emergency use authorization on the cobas Liat analyzer, showed abnormal PCR growth curves
- Product
- cobas SARS-CoV-2 & Influenza A/B assay cobas Liat- Reagents, 2019-Novel Coronavirus Nucleic Acid for use on the cobas Liat System, Catalog Number: 09211101190
- Where it went
- Nationwide WorldWide
- How much
- US: 143,823 kits Ex-US: 57,219 kits
uPath software 1.1 and uPath software 1.1 IVD-INSW, Material numbers 08991871001 and 09077332001
Z-0877-2021 · Class II · reported 2021-01-27 · Terminated
- Why it was recalled
- When a user creates a measurement tool annotation in the uPath Enterprise software version 1.1, the measurement value is incorrectly calculated when the measurement is viewed in "Split View" viewing mode and the slides within the case are scanned at different magnifications.
- Product
- uPath software 1.1 and uPath software 1.1 IVD-INSW, Material numbers 08991871001 and 09077332001
- Where it went
- Domestic distribution to Maryland and Michigan. International distribution to France, Greece, Italy, Poland, Turkey, Brazil, India, and Singapore.
- How much
- 27
The cobas z 480 analyzer including dedicated software for IVD use is a plate-based automated amplification and
Z-0846-2021 · Class II · reported 2021-01-20 · Terminated
- Why it was recalled
- Dirty Lens May Cause Invalid or False Positive Results
- Product
- The cobas z 480 analyzer including dedicated software for IVD use is a plate-based automated amplification and detection system for nucleic acids. The analyzer is intended to be used as an in-vitro diagnostic or screening system providing real time PCR amplification and detection for human samples within the system. The cobas x 480 instrument and cobas z 480 analyzer are to be used by laboratory professionals trained in laboratory techniques and by instruction on the use of the system and analyzer. In the U.S. the cobas z 480 analyzer is used for automated amplification and detection purposes for the following assays: cobas¿ 4800 BRAF V600 Mutation Test cobas¿ Cdiff Test for use on the cobas¿ 4800 System cobas¿ CT/NG v2.0 Test cobas¿ EGFR Mutation Test v2 cobas¿ Factor II and Factor V Test cobas¿ 4800 HPV Test cobas¿ HSV 1 and 2 Test for use on the cobas¿ 4800 System cobas¿ KRAS Mutation Test cobas¿ MRSA/SA Test for use on the cobas¿ 4800 System
- Where it went
- Worldwide distribution - US Nationwide distribution and the countries of Canada, Germany, Italy, Spain, United Kingdom, France, Austria, Turkey, Belgium, Poland, Portugal, Greece, Netherlands, Switzerland, Czech Republic, Romania, Sweden, Norway, Denmark, Hungary, Ireland, Slovakia, Croatia, Bulgaria, Finland, Lithuania, Bosnia-Herz, Slovenia, Iceland, Estonia, Australia, Cambodia, China, Hong Kong, India, Indonesia, Japan, Malaysia, Mongolia, Myanmar, New Zealand, Pakistan, Philippines, Singapore, South Korea, Taiwan, Thailand, Vietnam, Argentina, Aruba, Bahamas, Barbados, Belize, Brazil, Chile, Colombia, Costa Rica, Cuba, Dominican Rep., Ecuador, El Salvador, Guatemala, Honduras, Jamaica, Mexico, Panama, Paraguay, Peru, Uruguay, Venezuela, Iran, Israel, Kazakhstan, Kosovo, Lebanon, Macedonia, Oman, Russia, Saudi Arabia, South Africa, Sudan, Ukraine, UAE, Serbia, Montenegro, Algeria, Azerbaijan, Botswana, Burkina-Faso, Ethiopia, French Guayana, Gabon, Ghana, Guadeloupe, Lesotho, Martinique, Morocco, Nicaragua, Senegal, Sri Lanka, Tanzania, Tunisia, Uzbekistan, Zambia.
- How much
- 597 units US; 3411 units OUS
MagNA Pure 96 Instrument, clinical sample concentrator, Material number 06541089001 - Product Usage: This pro
Z-2551-2020 · Class II · reported 2020-07-22 · Terminated
- Why it was recalled
- When using Sample Transfer protocol version 3.0, the drop catcher is not activated on the MagNA Pure 96 instrument, which introduces a potential risk for cross-contamination leading to erroneous results.
- Product
- MagNA Pure 96 Instrument, clinical sample concentrator, Material number 06541089001 - Product Usage: This protocol is intended for pipetting samples into a MagNA Pure 96 Processing Cartridge (purification rack position 1) before a purification run.
- Where it went
- Worldwide distribution - US Nationwide distribution.
- How much
- 917
MagNA Pure 24 System, GMMI: 07290519001 Product Usage: The MagNA Pure 24 System is a fully automated clin
Z-1956-2018 · Class II · reported 2018-06-06 · Terminated
- Why it was recalled
- Cross-contamination of samples has been reported when running the existing protocol on the system with the rack-based purification run.
- Product
- MagNA Pure 24 System, GMMI: 07290519001 Product Usage: The MagNA Pure 24 System is a fully automated clinical sample extractor. It extracts nucleic acids from various sample types, sample tubes, and volume inputs for multiple downstream applications. The main features of the system are : Scalable purification of 1 to 24 samples Primary/secondary tube handling Inventory and sample management via barcodes Efficient order management via host The MagNA Pure 24 System offers 4 run types: Purification (rack) run Purification (cartridge) run Post Elution run Sample transfer run
- Where it went
- Worldwide Distribution - US Nationwide in the states of: CA, GA, HI, IN, MD, ME, MI, MN, NC, NY, PA, VI, and WI. The products were distributed to the following foreign countries: Austria, Belgium, Brazil, Chile, China, Columbia, Costa Rica, Czech Republic, Denmark, France, Germany, Guatemala, Hong Kong, Hungary, India, Israel, Italy, Japan, Mexico, Netherlands, Norway, Poland, Singapore, Slovenia, South Africa, South Korea, Spain, Switzerland, Taiwan, UAE, United Kingdom, Vietnam.
- How much
- 163 units
Nucleic Acid test intended for screening for MRSA/SA. Each kit has 20 tubes. in vitro diagnostic.
Z-1195-2018 · Class II · reported 2018-04-04 · Terminated
- Why it was recalled
- The cobas MRSA/SA tests may have decreased performance compared to the analytical sensitivity for MSRA detection. A screening failure can lead to potential infection in the colonized patient being tested as well as the spread of MSRA to others. The United States is not impacted, as the cobas MRSA/SA nucleic acid test for use on the cobas liat system is not available in the US.
- Product
- Nucleic Acid test intended for screening for MRSA/SA. Each kit has 20 tubes. in vitro diagnostic.
- Where it went
- Worldwide distribution. Austria, Denmark, Germany, Singapore, Netherlands, Hong Kong, and Switzerland. US product is not affected.
- How much
- 136 kits
LightMix¿ Zika rRT-PCR Test The LightMix¿ Zika rRT-PCR Test is a real-time RT-PCR test intended for the quali
Z-0750-2017 · Class II · reported 2016-12-21 · Terminated
- Why it was recalled
- The LightCycler¿ 480 algorithm used for the LightMix¿ Zika rRT-PCR Test, EUA (catalog number 07987897001) occasionally (~1% of the time) calls a positive result for a negative sample if there is an inflection point in the fluorescence signal.
- Product
- LightMix¿ Zika rRT-PCR Test The LightMix¿ Zika rRT-PCR Test is a real-time RT-PCR test intended for the qualitative detection of RNA from the Zika virus in serum or EDTA plasma from individuals meeting CDC Zika virus clinical criteria (e.g., clinical signs and symptoms associated with Zika virus infection) and/or CDC Zika virus epidemiological criteria (e.g., history of residence in or travel to a geographic region with active Zika transmission at the time of travel, or other epidemiologic criteria for which Zika virus testing may be indicated). Testing is limited to laboratories certified under the Clinical Laboratory Improvement Amendments of 1988 (CLIA), 42 U.S.C. ¿263a, to perform high complexity tests, or by similarly qualified non-U.S. laboratories. Results are for the identification of Zika virus RNA. Zika virus RNA is generally detectable in serum during the acute phase of infection (approximately 7 days following onset of symptoms, if present). Positive results are indicative of current infection. Laboratories are required to report all positive results to the appropriate public health authorities. Within the United States and its territories positive results must be...
- Where it went
- Nationwide Distribution
- How much
- 24 pieces
cobas¿ Liat¿ Analyzer
Z-2216-2016 · Class II · reported 2016-07-27 · Terminated
- Why it was recalled
- Device was released with default pcal/gain settings for photometers instead of the pcal/gain settings that are required for release. The default settings can potentially lead to the generation of erroneous or invalid results.
- Product
- cobas¿ Liat¿ Analyzer
- Where it went
- Distributed in NC and WA.
- How much
- 2
cobas EGFR Mutation Test V2 Materials number CE-IVD: EGFR v2: 07248563190 cfDNA: 07247737190 Device Ide
Z-2254-2016 · Class II · reported 2016-07-27 · Terminated
- Why it was recalled
- During internal studies using contrived plasma specimens, several mutations (L8568R, Exon 19 deletion, T790M) inconsistently generated "No Mutation Detected" (ie False Negative ) result with the cobas EGFR mutation Text V2.0 when utilizing the cobas cfDNA Sample Preparation kit.
- Product
- cobas EGFR Mutation Test V2 Materials number CE-IVD: EGFR v2: 07248563190 cfDNA: 07247737190 Device Identifier: EGFR v2.0: 00875197005448 cfDNA: 00875197005424 Product Usage: A real time PCR Test for the qualitative detection and identifications of mutations n exons 18, 19, 20 and 21 of the epidermal growth factor receptor (EGFR) gene in DNA derived from formalin-fixed paraffin-embedded (FFPET) tumor tissue or plasma from non-small cell lung cancer (NSCLC) patients. The test also is intended to be used as an aid in selecting patients with NSCLC for therapy with an EGFR tyrosine kinase inhibitor (TKI).
- Where it went
- Foriegn Distribution Austria, Belgium, Croatia, Czech Republic, Denmark, France, Germany, Greece, Hungary , Italy, Lithuania, Luxembourg, Netherlands, Norway, Poland, Romania, Slovakia, Slovenia, Spain, Switzerland, Turkey, United Kingdom cfDNA: Austria, Belgium, Croatia, Czech Republic, Denmark, France, Germany, Greece, Hungary , Italy, Lithuania, Luxembourg, Netherlands, Poland, Romania, Slovakia, Slovenia, Spain, Switzerland, Turkey, United Kingdom
- How much
- 735 devices EGFR; 509 devices cfDNA
cobas¿ Liat Influenza A/B Quality Control Kit; For use with cobas¿ Liat Influenza A/B Assay.
Z-2203-2016 · Class III · reported 2016-07-20 · Terminated
- Why it was recalled
- Kit labeled with the incorrect expiration date.
- Product
- cobas¿ Liat Influenza A/B Quality Control Kit; For use with cobas¿ Liat Influenza A/B Assay.
- Where it went
- Distributed in the states of: TX, NY, OR, HI, MD, PA, NC, MA, IA, WA, OR, AK, ME, MN, VA, MT, PA, and LA.
- How much
- 194 distributed kits
cobas¿ EGFR Mutation Test, v2 and cobas¿ cfDNA Sample Preparation Hungarian Translation Instructions for Use
Z-1830-2016 · Class II · reported 2016-06-01 · Terminated
- Why it was recalled
- An error was found within the Hungarian translations of the cobas¿ EGFR Mutation Test v2 Instructions for Use (M/N 07340761001-01HU, Doc Rev. 1.0, Dated 08/2015) and the cobas¿ cfDNA Sample Preparation Kit Instructions for Use (M/N 07573758001-01HU, Doc. Rev. 1.0, Dated 05/2015).
- Product
- cobas¿ EGFR Mutation Test, v2 and cobas¿ cfDNA Sample Preparation Hungarian Translation Instructions for Use
- Where it went
- Hungary
- How much
- 8 kits
Hand-Held Scanner USB IT3800 For sample identification and tracking when used with various systems
Z-1578-2016 · Class II · reported 2016-05-04 · Terminated
- Why it was recalled
- The hand-held barcode scanner model IT3800 used with the COBAS AmpliPrep instrument mis-identified a sample barcode ID.
- Product
- Hand-Held Scanner USB IT3800 For sample identification and tracking when used with various systems
- Where it went
- Nationwide Distribution
- How much
- 6,939 pieces
cobas Liat Analyzer, for in vitro diagnostic use.
Z-2543-2015 · Class II · reported 2015-09-09 · Terminated
- Why it was recalled
- Due to a supplier issue, the incorrect green and amber LED components were used in the manufacture of the LED printed circuit board assemblies (PCBA) in certain cobas Liat Analyzers.
- Product
- cobas Liat Analyzer, for in vitro diagnostic use.
- Where it went
- US Distribution to the states of :TX and NC.
- How much
- 5 pieces
cobas¿ EGFR Mutation Test epidermal growth factor receptor (EGFR) gene DNA assay
Z-1320-2015 · Class III · reported 2015-04-01 · Terminated
- Why it was recalled
- False positive results for Exon 20 insertion mutations are being detected with the cobas¿ EGFR Mutation Test, kit batch T08661.
- Product
- cobas¿ EGFR Mutation Test epidermal growth factor receptor (EGFR) gene DNA assay
- Where it went
- Foreign
- How much
- 190 kits
cobas 4800 KRAS AMP/DET 24T CE-IVD Mutation Test; CE-IVD 5852170190. Intended for the identification of mut
Z-0999-2015 · Class III · reported 2015-01-28 · Terminated
- Why it was recalled
- cobas KRAS Mutation Kit T10786 is generating invalid results for the Mutant Control and/or KRAS Calibrator.
- Product
- cobas 4800 KRAS AMP/DET 24T CE-IVD Mutation Test; CE-IVD 5852170190. Intended for the identification of mutations in codons 12,13 and 61 of the KRAS Gene in DNA derived from formalin-fixed paraffin-embedded human colorectal and non-small cell lung cancer tissues.
- Where it went
- Foreign Distributed.
- How much
- 660 pieces
cobas¿ PCR Urine Kit 100 PKT IVD cobas¿ PCR Female Swab Kit 100 PKT IVD cobas¿ PCR media 100T IVD cobas¿ PC
Z-1111-2014 · Class II · reported 2014-03-05 · Terminated
- Why it was recalled
- Numerous complaints have been filed that leaking cobas ¿ PCR media 4.3 mL IVD have been received from different lots of the cobas ¿ PCR Urine kits, cobas ¿ PCR Female Swab kits, and cobas ¿ PCR media kits.
- Product
- cobas¿ PCR Urine Kit 100 PKT IVD cobas¿ PCR Female Swab Kit 100 PKT IVD cobas¿ PCR media 100T IVD cobas¿ PCR Female Swab Kit 100 PKT JPN-IVD Roche Molecular Systems, Inc. Branchburg, NJ 08876 USA Roche Diagnostics 9115 Hague Road Indianapolis, IN 46250-0457 The cobas¿¿ PCR media serves as a nucleic acid stabilizing transport and storage medium for gynecological specimens and is contained in the cobas¿¿ PCR Female Swab Kit, cobas¿¿ PCR Urine kit, and cobas¿¿ PCR media 100 T kit. -The cobas¿¿ PCR Urine Sample Kit is used to collect and transport urine specimens. Use this collection kit only with the cobas¿¿ CT/NG Test. - The cobas¿¿ PCR Female Swab Sample Kit is used to collect and transport endocervical and vaginal swab specimens. Use this collection kit only with the cobas¿¿ CT/NG Test NOTE: This collection kit should not be used for collection of female urine specimens. o For endocervical swab specimens, collections are to be performed by a clinician. o For vaginal swab specimens, collections are to be performed by a clinician or by the patient (self-collection) -In US labeling, it indicates Self collection in a clinical setting. - In ex-US labeling, it indicates...
- Where it went
- Nationwide Distribution
- How much
- 84 kit batches
KIT cobas 4800 HPV AMP/DET 240T / 960T US-IVD, CE-IVD Roche Molecular System, Inc. 1080 US highway 202 South
Z-2173-2013 · Class II · reported 2013-09-18 · Terminated
- Why it was recalled
- During an internal investigation, a formulation error that occurred was identified during the manufacture of the cobas¿ 4800 HPV Master Mix reagent that was packaged in four (4) cobas¿ 4800 AMP/DET kits, US- and CE-IVD (240 and 960 test kit configurations). Examination of the batch production record of the material revealed there was an error in the tare weight used for the carboy during the fina
- Product
- KIT cobas 4800 HPV AMP/DET 240T / 960T US-IVD, CE-IVD Roche Molecular System, Inc. 1080 US highway 202 South Branchburg, NJ 08876 USA Roche Diagnostics 9115 Hague Road Indianapolis, IN 46250-0457 USA The cobas¿ HPV Test is a qualitative in vitro test for the detection of Human Papillomavirus in patient specimens. The test utilizes amplification of target DNA by the Polymerase Chain Reaction (PCR) and nucleic acid hybridization for the detection of 14 high-risk (HR) HPV types in a single analysis. The test specifically identifies types HPV16 and HPV18 while concurrently detecting the rest of the high risk types (31, 33, 35, 39, 45, 51, 52, 56, 58, 59, 66 and 68). The cobas¿ HPV Test is indicated: (a) To screen patients 21 years and older with ASC-US (Atypical squamous cells of undetermined significance) cervical cytology test results to determine the need for referral to colposcopy. (b) To be used in patients 21 years and older with ASC-US cervical cytology results, to assess the presence or absence of high-risk HPV genotypes 16 and 18. This information, together with the physicians assessment of cytology history, other risk factors, and professional guidelines, may be used...
- Where it went
- Worldwide Distribution - USA (nationwide) including the countries of Austria, Australia, Belgium, Brazil, Czech Rep, Canada, Croatia, Columbia, Denmark, Dominican Republic, Germany, Ecuador, France, Japan, Greenland, Mexico, Italy, New Zealand, Netherlands, Peru, Norway, Singapore, Romania, South Africa, Spain, South Korea, Sweden, Switzerland and UK.
- How much
- US-IVD: 350 Kits; CE-IVD: 441 KITS
cobas¿ 4800 system z480 instrument. Integrates fully automated total nucleic acid isolation directly fro
Z-1346-2013 · Class II · reported 2013-05-29 · Terminated
- Why it was recalled
- In rare instances, channel shifted results have been generated with cobas¿ 4800 assays run on v1.1.1 of the cobas¿ 4800 system. Raw data review indicates that, in these cases, all signals are shifted by one channel: channel 1 results report as channel 2, channel 2 results report as channel 3, channel 3 results report as channel 4, and channel 4 results report as channel 1. In the reported
- Product
- cobas¿ 4800 system z480 instrument. Integrates fully automated total nucleic acid isolation directly from secondary sample tubes.
- Where it went
- Nationwide Distribution.
- How much
- 425 instruments
COBAS TaqMan Mycobacteria tuberculosis (MTB) Test FOR IN VITRO DIAGNOSTIC USE.
Z-0762-2013 · Class II · reported 2013-02-06 · Terminated
- Why it was recalled
- The COBAS TaqMan MTB Test Definition Files (TDF) v3.0, for both CE-IVD and JPN-IVD tests, being used with AMPLILINK software version 3.3 series and COBAS TaqMan MTB Test Kits, both CE-IVD and JPN-IVD, have an incorrect Target Elbow Max cutoff value of 48 creating the potential for false negative results to be generated for patient samples with Target Elbows in the range of 48 to 50.
- Product
- COBAS TaqMan Mycobacteria tuberculosis (MTB) Test FOR IN VITRO DIAGNOSTIC USE.
- Where it went
- Worldwide Distribution - Foreign (22 EU countries - Austria, Belgium, Bulgaria, Croatia, Cypress, Czech Republic, Denmark, Germany, Finland, France, Greenland, Hungary, Iceland, Italy, Luxembourg, Netherland, Norway, Sweden, Switzerland, Spain, Turkey, UK); (41 Rest of World countries - See Attachment for full country distribution + Japan, Portugal and Mexico)
- How much
- 335 CE-IVD TDFs; 48 JPN-IVD TDFs
COBAS AmpliPrep Instrument (CAP) with AMPLILINK (AL) Software v.3.3.5 Automated sample processing instrumen
Z-0614-2013 · Class II · reported 2013-01-02 · Terminated
- Why it was recalled
- Certain COBAS AmpliPrep instruments using AMPILINK software v.3.3.4 had the sample clot detection flagging feature disabled during quality control release resulting in samples that may not be flagged as having clots.
- Product
- COBAS AmpliPrep Instrument (CAP) with AMPLILINK (AL) Software v.3.3.5 Automated sample processing instrument used with CAP/CA and CAP/CTM. Roche Molecular Systems, Inc. 1080 US Highway 202 South Branchburg, NJ 08876 USA Made in Switzerland
- Where it went
- Distributed in the states of GA, CA, NC, and MN.
- How much
- 7 units
DataCare POC is an information management system that provides data management functionality for managing po
Z-0493-2013 · Class II · reported 2012-12-19 · Terminated
- Why it was recalled
- Roche Molecular Systems, Inc. has become aware of a device-associated diagnostic software issue.
- Product
- DataCare POC is an information management system that provides data management functionality for managing point-of -care testing data.
- Where it went
- Nationwide Distribution
- How much
- 126 units
The MagNA Pure 96 System (versions 1.0 and 2.0) is a sample preparation instrument for automated isolation
Z-0486-2013 · Class II · reported 2012-12-19 · Terminated
- Why it was recalled
- Roche Molecular Systems, Inc. has become aware of a device-associated diagnostic software issue.
- Product
- The MagNA Pure 96 System (versions 1.0 and 2.0) is a sample preparation instrument for automated isolation of nucleic acids in various types of biological materials. This is a general purpose instrument. There are no corresponding assays.
- Where it went
- Nationwide Distribution
- How much
- 13 units
Showing the 30 most recent of 42. 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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