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.
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 its cobas Liat Analyzer respiratory virus panel nucleic acid assay system because it can produce false positive results for SARS-CoV-2, Influenza A, and Influenza B tests. This means test results could be inaccurate, potentially leading to incorrect health decisions.
The device can produce false positive results for SARS-CoV-2, Influenza A, and Influenza B tests, which may show abnormal PCR growth curves. This means tests could incorrectly indicate an infection when there is none, or vice versa.
Users of the cobas Liat Analyzer with the catalog number 07341920190 are affected. Healthcare facilities using this device for emergency testing may be at risk of inaccurate results.
Check for the catalog number 07341920190 on the cobas Liat Analyzer. All units with this specific catalog number are affected.
Look for the catalog number 07341920190 on the cobas Liat Analyzer.
The cobas Liat Analyzer can produce false positive results for SARS-CoV-2, Influenza A, and Influenza B tests, which may show abnormal PCR growth curves.
If you have the cobas Liat Analyzer with catalog number 07341920190, it may give inaccurate test results for respiratory viruses, which could lead to incorrect health decisions.
Check the catalog number on your cobas Liat Analyzer; affected units have the catalog number 07341920190.
We’ve drafted a message you can send Roche to request your refund or repair — edit it as you like.
Subject: Recall Z-1414-2021 — Roche Roche Hello, I own a Roche that is covered by recall Z-1414-2021 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.
