Official recall notice
FDA DeviceClass IINotable
FDA Recall: Product Name: ID NOW" Influenza A & B 2 Model/Catalog Number: 427-000 Software Version: Not Applic
- Recall date
- 2026-03-25
- Category
- Medical Device
- FDA class
- Class II
Why it was recalled
Hazard
It was confirmed that the impacted lot has a higher occurrence of invalid rates when compared to the product Instructions for Use.
Recommended action
What to do
111984 units
Product description
It was confirmed that the impacted lot has a higher occurrence of invalid rates when compared to the product Instructions for Use.