FDA-Device2023-02-15Class II
cobas SARS-CoV-2 & Influenza A/B Qualitative assay for use on the cobas 6800/8800 Systems; Material number 09233474190
Roche Molecular Systems, Inc.
Hazard
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.
Sold states
Domestic distribution nationwide. Foreign distribution worldwide.
Affected count
18,071 kits (US); 30,085 kits (OUS)
Manufactured in
1080 Us Highway 202 S, Branchburg, NJ, United States
Products
cobas SARS-CoV-2 & Influenza A/B Qualitative assay for use on the cobas 6800/8800 Systems; Material number 09233474190
Official notice
https://www.accessdata.fda.gov/scripts/ires/index.cfm?Product=Z-1104-2023Don't want to check this manually?
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