Roche recalls cobas SARS-CoV-2 & Influenza A/B Test for false positive results. Affected units have Catalog Number 09211101190 and Lot 10119Z.
Customers have reported an increased number of false positive SARS-CoV-2 results.
Roche is recalling its cobas SARS-CoV-2 and Influenza A/B tests for the cobas Liat System due to reported false positive results. This could lead to incorrect health decisions if the test shows a positive result when the person is not infected.
False positive results can occur when the test shows a positive result for SARS-CoV-2 when the person is not actually infected. This may lead to unnecessary health concerns or actions based on incorrect test outcomes.
Users of the cobas SARS-CoV-2 & Influenza A/B test for the cobas Liat System with Catalog Number 09211101190 and Lot 10119Z are affected. People who rely on these tests for accurate health screening are most at risk.
Check for the Catalog Number 09211101190 and Lot 10119Z on the test kit. The product is sold for use with the cobas Liat System.
Look for Catalog Number 09211101190 and Lot 10119Z on the test kit.
Customers have reported an increased number of false positive SARS-CoV-2 results with this test.
Check the Catalog Number 09211101190 and Lot 10119Z on the test kit. No specific action is required beyond checking the details.
The recall record does not mention any remedy or fix for this issue.
We’ve drafted a message you can send Roche to request your refund or repair — edit it as you like.
Subject: Recall Z-2498-2021 — Roche Roche Hello, I own a Roche that is covered by recall Z-2498-2021 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.
