Z-1565-2026 Class II Ongoing
Recall Details
- Product Type
- Devices
- Report Date
- March 25, 2026
- Initiation Date
- February 9, 2026
- Termination Date
- N/A
- Voluntary/Mandated
- Voluntary: Firm initiated
- Product Quantity
- 111984 units
Product Description
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
Reason for Recall
It was confirmed that the impacted lot has a higher occurrence of invalid rates when compared to the product Instructions for Use.
Distribution Pattern
US Nationwide distribution.
Code Information
List Number: 427-000; UDI-DI: 10811877010422; Lot Number: 000X133126; Expiry: 2027 02 21;