Device product
cobas SARS-CoV-2 & Influenza A/B Qualitative assay for use on the cobas 6800/8800 Systems; Material number 09233474190
Z-1104-2023
Product summary
- Event
- Event 91482
- Status
- Ongoing
- Classification
- Class II
- Quantity
- 18,071 kits (US); 30,085 kits (OUS)
- Official record key
device-enforcement:Z-1104-2023
Official wording
Reason: 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.
Code information: UDI-DI 00875197006674 All in-date lots
Distribution pattern: Domestic distribution nationwide. Foreign distribution worldwide.
Derived failure modes
-
Unknown
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.