Roche recalls cobas SARS-CoV-2 and Influenza A/B tests that may produce false negative results, causing unnecessary testing and delays in treatment. Affected tests were sold with specific model numbers and lot dates.
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 certain SARS-CoV-2 and Influenza A/B tests that can give false negative results. This may lead to extra testing, psychological stress, and delays in getting proper treatment for flu.
The tests can sometimes show no flu when it's actually present. This might mean patients need more tests, cause anxiety, and delay treatment for flu.
Healthcare professionals using the cobas 5800/6800/8800 systems with the specific test material numbers. Those most at risk are patients who rely on these tests for accurate flu diagnosis.
Check for the material number 09446125190 on the test kit. The tests were sold with specific lot dates and were used on cobas 5800/6800/8800 systems.
Look for the material number 09446125190 on the test kit packaging.
The firm received customer complaints about false negative influenza A results, which could lead to extra testing, psychological distress, and delays in flu treatment.
Check the test kit for the material number 09446125190. If you have it, stop using it and contact Roche for guidance.
No, the hazard is limited to false negative results, which may cause unnecessary testing and delays but does not involve physical harm.
We’ve drafted a message you can send Roche to request your refund or repair — edit it as you like.
Subject: Recall Z-1105-2023 — Roche Roche Hello, I own a Roche that is covered by recall Z-1105-2023 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.
