Roche Molecular Systems, Inc. recalls cobas SARS-CoV-2 & Influenza A/B Qualitative nucleic acid test for use on the cobas 5800/6800/8800 Systems; Material Nu…
- Recall date
- December 21, 2022
- Source
- U.S. Food & Drug Administration (FDA) — enforcement report
- Recall number
- Z-1105-2023
- FDA classification
- Class II
- Brand / firm
- Roche Molecular Systems, Inc.
- Sold / distributed
- Domestic distribution nationwide. Foreign distribution worldwide.
Why it was 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.
Class II means using this product may cause temporary or medically reversible health problems; the chance of serious harm is remote.
What was recalled
cobas SARS-CoV-2 & Influenza A/B Qualitative nucleic acid test for use on the cobas 5800/6800/8800 Systems; Material Number 09446125190
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