CLASS II ONGOING Device recall · Reported 21 Apr 2021 · FDA Enforcement Report
cobas Sars-CoV-2 & Influenza A/B assay cobas Liat- Reagents recalled
Roche Molecular Systems is recalling cobas Sars-CoV-2 & Influenza A/B assay cobas Liat- Reagents, 2019-Novel Coronavirus, distributed nationwide in the US. The recall was initiated on 25 Mar 2021 and the FDA has classified it as Class II.
Check your package
Stop using the device if the notice says to, and contact the manufacturer or your healthcare provider for the correction or replacement.
Recall details
- Recall number
- Z-1413-2021
- FDA event ID
- 87622
- Recalling firm
- Roche Molecular Systems, Branchburg, NJ
- Classification
- Class II
- Status
- Ongoing
- Recall initiated
- 25 Mar 2021
- FDA classified
- 12 Apr 2021
- Reported
- 21 Apr 2021
- Type
- Voluntary: Firm initiated
- Customers notified by
- Letter
- Reason category
- Potency & Assay
- Device type
- Test Kits & Diagnostics
Timeline
| 25 Mar 2021 | Recall initiated by company | |
| 12 Apr 2021 | Classified by FDA | +18 days |
| 21 Apr 2021 | Published in enforcement report | +9 days |
Companies usually start a recall weeks before the FDA classifies and publishes it; the gap above is that lag.
Reason for recall
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
Potency and specification recalls happen when a batch tests outside its approved limits for strength, purity or dissolution, which can mean the dose delivered is higher or lower than labelled.
Product as listed by the FDA
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 was distributed
Nationwide WorldWide
Questions about this recall
Why was it 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
Which lots are affected?
All lot numbers
Where was it sold?
Nationwide WorldWide
What should I do if I have it?
Stop using the device if the notice says to, and contact the manufacturer or your healthcare provider for the correction or replacement.
What does Class II mean?
Class II means the product may cause temporary or medically reversible health problems, or the probability of serious harm is remote.
Read the official FDA notice · Source record retrieved 26 Sep 2026. The FDA describes openFDA data as unvalidated; the official notice takes precedence. This page reports the record and gives no medical advice.
Other products in this recall event
1 other product · FDA event 87622This product is part of a recall event; the main page for the event is cobas Liat Analyzer: respiratory virus panel nucleic acid recalled.
| Reported | Class | Recall | Company | Reason | Where |
|---|---|---|---|---|---|
| CLASS II | cobas Liat Analyzer: respiratory virus panel nucleic acid recalled | Roche Molecular Systems | Potency & Assay | Nationwide |
More recalls from Roche Molecular Systems
All 42| Reported | Class | Recall | Company | Reason | Where |
|---|---|---|---|---|---|
| Device | CLASS II | cobas Sars-CoV-2 & Influenza A/B Qualitative assay recalled | Roche Molecular Systems | Potency & Assay | Nationwide |
| Device | CLASS II | cobas Influenza A/B & RSV UC recalled by Roche Molecular Systems | Roche Molecular Systems | Other | Nationwide |
| Device | CLASS II | cobas Sars-CoV-2 & Influenza A/B Qualitative nucleic acid recalled | Roche Molecular Systems | Other | Nationwide |
| Device | CLASS II | cobas 5800 instrument, Material No. recalled by Roche Molecular Systems | Roche Molecular Systems | Other | NJ |
| Device | CLASS II | cobas LiatSystem, respiratory virus panel nucleic acid recalled | Roche Molecular Systems | Potency & Assay | Nationwide |
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