Roche recalls cobas Influenza A/B & RSV tests for false negative results, which may delay flu treatment. Affected units sold with cobas 6800/8800 systems.
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 influenza and RSV tests that may give false negative results for flu A, potentially delaying treatment and causing unnecessary testing. This could lead to psychological distress and missed targeted therapy.
The test may show no flu A when it's actually present, leading to extra tests, patient anxiety, and delayed treatment. This happens due to the test's inability to detect flu A in some cases.
Healthcare professionals using the cobas 6800/8800 systems with the recalled test kits. Those most at risk are providers testing flu samples where false negatives could delay critical treatment.
Look for the cobas Influenza A/B & RSV UC test with material number 09233962190 sold with cobas 6800/8800 systems. All in-date lots are affected.
Verify the material number 09233962190 on the test kit label to confirm if it's affected.
The firm received customer complaints about false negative flu A results and late flu A target Ct values, which may delay treatment and cause psychological distress.
The recall record does not specify a remedy, so contact Roche directly for guidance.
The recall indicates a risk of false negatives, which could delay treatment, but the test itself is not dangerous.
We’ve drafted a message you can send Roche to request your refund or repair — edit it as you like.
Subject: Recall Z-1106-2023 — Roche Roche Hello, I own a Roche that is covered by recall Z-1106-2023 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.
