Roche recalls cobas SARS-CoV-2 and Influenza A/B assay reagents that may produce false positive results for coronavirus and flu tests. Affected units include all lots of the cobas Liat system reagents.
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
Roche is recalling reagents used in their cobas Liat system for testing SARS-CoV-2 and influenza. These reagents may give false positive results, meaning they could incorrectly show an infection when there isn't one. This could lead to unnecessary testing or anxiety.
The reagents may produce abnormal PCR growth curves, which can cause the test to show a positive result when there's no actual infection. This could lead to false positive results for SARS-CoV-2 or influenza.
People who use the cobas Liat system for testing SARS-CoV-2 or influenza may be affected. Those with the reagents from the recalled lots are most at risk of getting false positive results.
Check if you have the cobas SARS-CoV-2 & Influenza A/B assay reagents with catalog number 09211101190. All lots of these reagents are affected by the recall.
Verify if your reagents have the catalog number 09211101190 and are from the affected lots.
The recall does not require stopping use; it only addresses potential false positive results.
The recall does not specify a remedy, so you can continue using them but be aware of possible false positives.
All lots of the cobas SARS-CoV-2 & Influenza A/B assay reagents with catalog number 09211101190 are affected.
We’ve drafted a message you can send Roche to request your refund or repair — edit it as you like.
Subject: Recall Z-1413-2021 — Roche Roche Hello, I own a Roche that is covered by recall Z-1413-2021 from Roche. I’m writing to arrange the remedy described in the recall (a refund, repair, or replacement as applicable). Could you please tell me the next steps to resolve this? Thank you.
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The facts (hazard, remedy, dates, manufacturer) are pulled from the official FDA recall record. The plain-language summary and step-by-step checklist are written by GovInfoNow to make the official notice easier to act on — they don’t replace it.
