Roche Molecular Systems, Inc. recalls
Every recall we track for Roche Molecular Systems, Inc. — 14 in all, from 2017–2022 — plus the complaints and injury reports the public filed about them.
Recalls per year, by danger level
Recalls from Roche Molecular Systems, Inc. peaked in 2021 (5); 14 since 2017.
All FDA recall records for Roche Molecular Systems, Inc. since 2017, counted by recall date (one bar per calendar year; 2026 is partial). Danger level is GovInfoNow’s plain-language rating; “not yet rated” records are still being written up.
| Year | Stop using now | Use caution | Lower risk | Not yet rated | Total |
|---|---|---|---|---|---|
| 2017 | 0 | 0 | 1 | 0 | 1 |
| 2018 | 0 | 0 | 1 | 0 | 1 |
| 2019 | 0 | 0 | 0 | 0 | 0 |
| 2020 | 0 | 0 | 3 | 0 | 3 |
| 2021 | 0 | 0 | 5 | 0 | 5 |
| 2022 | 0 | 0 | 4 | 0 | 4 |
| 2023 | 0 | 0 | 0 | 0 | 0 |
| 2024 | 0 | 0 | 0 | 0 | 0 |
| 2025 | 0 | 0 | 0 | 0 | 0 |
| 2026 (to date) | 0 | 0 | 0 | 0 | 0 |
What to do if you have a recalled Roche Molecular Systems, Inc. product
- Match the model, catalog or lot number on your device to the recall.
- Ask the prescribing clinician or supplier what to do — many device recalls are corrections, not removals.
- Report problems to FDA MedWatch.
All Roche Molecular Systems, Inc. recalls
11 shown- Lower riskMedical device
Roche Molecular Systems, Inc. recalls cobas SARS-CoV-2 & Influenza A/B Qualitative nucleic acid test for use on the cobas 5800/6800/8800 Systems; Material
Roche recalls cobas SARS-CoV-2 and Influenza A/B tests that may produce false negative results, causing unnecessary testing and delays in treatment. Affected tests were sold with specific model numbers and lot dates.
RocheDec 21, 2022 - Lower riskMedical device
Roche Molecular Systems, Inc. recalls cobas 5800 instrument, Material No. 08707464001. Used for automated Polymerase Chain Reaction (PCR) based Nucleic Acid
Roche recalls cobas 5800 PCR instruments with Material No. 08707464001 due to reported false positives and invalid results, potentially causing delayed diagnoses.
RocheSep 8, 2022 - Lower riskMedical device
Roche Molecular Systems, Inc. recalls cobas LiatSystem, respiratory virus panel nucleic acid assay system, Material Number 07341920190
Roche recalls a small number of cobas Liat analyzer units with high noise levels causing false positive Influenza B results. Affected units have specific serial numbers and material numbers.
RocheNov 16, 2021 - Lower riskMedical device
Roche Molecular Systems, Inc. recalls cobas EGFR Mutation Test v2-Somatic gene mutation detection system Catalog Number :07248563190
Roche recalls cobas EGFR Mutation Test v2 due to false mutation results for Ex20Ins mutations, potentially leading to incorrect cancer treatment decisions. Affected units include all lot numbers of the system.
RocheSep 3, 2021 - Lower riskMedical device
Roche Molecular Systems, Inc. recalls cobas SARS-CoV-2 & Influenza A/B Test for use on the cobas Liat System, Catalog Number 09211101190
Roche recalls cobas SARS-CoV-2 & Influenza A/B Test for false positive results. Affected units have Catalog Number 09211101190 and Lot 10119Z.
RocheAug 4, 2021 - Lower riskMedical device
Roche Molecular Systems, Inc. recalls cobas Liat Analyzer: respiratory virus panel nucleic acid assay system Catalog Number: 07341920190
Roche recalls cobas Liat Analyzer respiratory virus panel due to potential false positive results for SARS-CoV-2, Influenza A, and B tests. Affected units may show abnormal PCR growth curves.
RocheMar 25, 2021 - Lower riskMedical device
Roche Molecular Systems, Inc. recalls uPath software 1.1 and uPath software 1.1 IVD-INSW, Material numbers 08991871001 and 09077332001
Roche recalls uPath software versions 1.1 and 1.1 IVD-INSW due to incorrect measurement calculations when viewing slides in Split View mode at different magnifications.
RocheNov 23, 2020 - Lower riskMedical device
Roche Molecular Systems, Inc. recalls The cobas z 480 analyzer including dedicated software for IVD use is a plate-based automated amplification and
Roche recalls cobas z 480 analyzers for possible false positive results due to dirty lenses. Lab users should check lens cleanliness and follow manufacturer instructions.
RocheNov 19, 2020 - Lower riskMedical device
Roche Molecular Systems, Inc. recalls MagNA Pure 96 Instrument, clinical sample concentrator, Material number 06541089001 - Product Usage: This protocol is
Roche recalls MagNA Pure 96 clinical sample concentrators used with Sample Transfer protocol 3.0 due to cross-contamination risk. Affected units may cause erroneous lab results.
RocheJun 3, 2020 - Lower riskMedical device
Roche Molecular Systems, Inc. recalls MagNA Pure 24 System, GMMI: 07290519001 Product Usage: The MagNA Pure 24 System is a fully automated clinical sample
Roche recalls MagNA Pure 24 System due to reported cross-contamination of samples during rack-based purification runs. Affected units have specific model numbers and were sold for clinical use.
RocheMay 2, 2018 - Lower riskMedical device
Roche Molecular Systems, Inc. recalls Nucleic Acid test intended for screening for MRSA/SA. Each kit has 20 tubes. in vitro diagnostic.
Roche recalls certain MRSA/SA test kits due to potential reduced accuracy, risking missed infections. The US is unaffected as these tests aren't available here.
RocheOct 27, 2017
Roche Molecular Systems, Inc. recall questions
How many recalls has Roche Molecular Systems, Inc. had?
14 recalls from Roche Molecular Systems, Inc. are on record with U.S. safety agencies, from 2017–2022.
What is the most recent Roche Molecular Systems, Inc. recall?
Roche Molecular Systems, Inc. recalls cobas SARS-CoV-2 & Influenza A/B Qualitative nucleic acid test for use on the cobas 5800/6800/8800 Systems; Material, dated Dec 21, 2022. Every Roche Molecular Systems, Inc. recall is listed on this page, newest first.
What should I do if I have a recalled Roche Molecular Systems, Inc. product?
Match the model, catalog or lot number on your device to the recall. Ask the prescribing clinician or supplier what to do — many device recalls are corrections, not removals. Report problems to FDA MedWatch.
How do I get alerts for new Roche Molecular Systems, Inc. recalls?
Sign up for free email alerts on GovInfoNow — we check official CPSC, FDA, USDA and NHTSA data every day and email you only when a recall matches what you follow.