CLASS II Device recall · Reported 29 Sep 2021 · FDA Enforcement Report
cobas Sars-CoV-2 & Influenza A/B Test recalled
Roche Molecular Systems is recalling cobas Sars-CoV-2 & Influenza A/B Test for use on the cobas Liat System, distributed nationwide in the US. The recall was initiated on 4 Aug 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-2498-2021
- FDA event ID
- 88600
- Recalling firm
- Roche Molecular Systems, Branchburg, NJ
- Classification
- Class II
- Status
- Terminated
- Recall initiated
- 4 Aug 2021
- FDA classified
- 21 Sep 2021
- Reported
- 29 Sep 2021
- Type
- Voluntary: Firm initiated
- Reason category
- Other Reasons
- Device type
- Other Medical Devices
Timeline
| 4 Aug 2021 | Recall initiated by company | |
| 21 Sep 2021 | Classified by FDA | +48 days |
| 29 Sep 2021 | Published in enforcement report | +8 days |
Companies usually start a recall weeks before the FDA classifies and publishes it; the gap above is that lag.
Reason for recall
Customers have reported an increased number of false positive SARS-CoV-2 results.
Product as listed by the FDA
cobas SARS-CoV-2 & Influenza A/B Test for use on the cobas Liat System, Catalog Number 09211101190
Where it was distributed
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.
Nationwide ArkansasCaliforniaIllinoisIndianaKansasMaineMichiganMinnesotaMissouriNew YorkOregonTennesseeTexasWashingtonWisconsin
Questions about this recall
Is cobas Sars-CoV-2 & Influenza A/B Test for use on the cobas Liat System recalled?
Yes. Roche Molecular Systems recalled cobas Sars-CoV-2 & Influenza A/B Test for use on the cobas Liat System on 4 Aug 2021. The recall is Class II and its status is Terminated. Recall number Z-2498-2021.
Why was it recalled?
Customers have reported an increased number of false positive SARS-CoV-2 results.
Which lots are affected?
Lot 10119Z
Where was it sold?
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.
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 21 Sep 2026. The FDA describes openFDA data as unvalidated; the official notice takes precedence. This page reports the record and gives no medical advice.
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 | Lead & Heavy Metals | Nationwide |
| Device | CLASS II | cobas Influenza A/B & RSV UC recalled by Roche Molecular Systems | Roche Molecular Systems | Lead & Heavy Metals | Nationwide |
| Device | CLASS II | cobas Sars-CoV-2 & Influenza A/B Qualitative nucleic acid recalled | Roche Molecular Systems | Lead & Heavy Metals | Nationwide |
| Device | CLASS II | cobas 5800 instrument, Material No. recalled by Roche Molecular Systems | Roche Molecular Systems | Lead & Heavy Metals | Nationwide |
| Device | CLASS II | cobas LiatSystem, respiratory virus panel nucleic acid recalled | Roche Molecular Systems | Potency & Assay | Nationwide |
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