Potential health hazard — use of or exposure to this product may cause temporary or medically reversible adverse health consequences.
cobas SARS-CoV-2 & Influenza A/B Qualitative assay for use on Recalled by Roche Molecular Systems, Inc. Due to The firm received customer complaints regarding false negative...
What You Should Do
Stop using this product immediately. Do not consume, use, or distribute it.
Return the product to the place of purchase for a full refund. If you have questions, contact Roche Molecular Systems, Inc. directly.
Affected Products
cobas SARS-CoV-2 & Influenza A/B Qualitative assay for use on the cobas 6800/8800 Systems; Material number 09233474190
Quantity: 18,071 kits (US); 30,085 kits (OUS)
Why Was This Recalled?
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.
Where Was This Sold?
This product was distributed nationwide across all 50 states.
About Roche Molecular Systems, Inc.
Roche Molecular Systems, Inc. has 42 total recalls tracked by RecallDetector.
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Data sourced from the FDA (Device). Last updated March 26, 2026. View original report