Roche recalls cobas SARS-CoV-2 and Influenza A/B tests for false negative Flu A results, causing unnecessary testing and delays in treatment. Affected units have material number 09233474190.
The firm received customer complaints regarding false negative Influenza A (Flu A) results and late Flu A Target Ct values. A false negative influenza A result may lead to additional testing, psychological distress, and delays to targeted therapy for influenza as well as true diagnosis.
Roche is recalling its cobas SARS-CoV-2 and Influenza A/B tests for use on cobas 6800/8800 systems. The recall is due to false negative results for Influenza A, which could lead to extra testing, psychological distress, and delays in treatment.
The assay may produce false negative results for Influenza A, meaning infections go undetected. This can lead to additional testing, psychological distress, and delays in targeted treatment for influenza.
Healthcare facilities using the cobas 6800/8800 systems with the specified assay may be affected. Patients relying on these tests for Influenza A diagnosis could face unnecessary testing and treatment delays.
Check for the material number 09233474190 on the cobas SARS-CoV-2 & Influenza A/B assay. The product is sold with the cobas 6800/8800 systems and is in-date lots.
Look for material number 09233474190 on the cobas SARS-CoV-2 & Influenza A/B assay.
The recall is due to false negative Influenza A results, which may cause unnecessary testing, psychological distress, and delays in targeted treatment.
Check the material number on the assay. If it matches 09233474190, contact Roche for guidance.
The recall record does not mention a remedy or fix for the false negative results.
We’ve drafted a message you can send Roche to request your refund or repair — edit it as you like.
Subject: Recall Z-1104-2023 — Roche Roche Hello, I own a Roche that is covered by recall Z-1104-2023 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.
