Device product
Product Name: ID NOW" Influenza A & B 2 Model/Catalog Number: 427-000 Software Version: Not Applicable Product Description: Influenza A/B virus nucleic acid IVD, kit, nucleic acid technique Component: Not Applicable
Z-1565-2026
Product summary
- Event
- Event 98400
- Status
- Ongoing
- Classification
- Class II
- Quantity
- 111984 units
- Official record key
device-enforcement:Z-1565-2026
Official wording
Reason: It was confirmed that the impacted lot has a higher occurrence of invalid rates when compared to the product Instructions for Use.
Code information: List Number: 427-000; UDI-DI: 10811877010422; Lot Number: 000X133126; Expiry: 2027 02 21;
Distribution pattern: US Nationwide distribution.
Derived failure modes
-
Unknown
It was confirmed that the impacted lot has a higher occurrence of invalid rates when compared to the product Instructions for Use.