Product Name: ID NOW" Influenza A & B 2 Model/Catalog Number: 427-000 Software Version: Not Applicable Product Descripti
FDA device recall Z-1565-2026 · posted 2026-03-13 · Open, Classified
Recall details
- Recalling firm
- Abbott Diagnostics Scarborough, Inc.
- 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.
- Action taken
- On or about February 9, 2026 Product Removal Notice letters were sent to customers and distributors. Actions to be taken: " Quarantine and discontinue use of any remaining inventory of the impacted lot. " Count how many unused kit boxes (24 tests / 1 kit box) of remaining impacted inventory require replacement. " Complete and return the Customer Acknowledgment Form (Form must be fully completed, signed and returned to receive replacement product). " Complete the Customer Request for Replacement Product Form. " Customer Service will arrange replacement product and return of your product. " Retain this letter for your records. forward this notice to those you have further distributed or transferred product to.
- Root cause
- Under Investigation by firm
- Status
- Open, Classified
- Product code
- OZE
- Quantity affected
- 111984 units
- Distribution
- US Nationwide distribution.
- Date initiated
- 2026-02-09
- Date posted
- 2026-03-13
- Location
- Scarborough, ME
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Related 510(k) clearances
| Record | Firm | Date |
|---|---|---|
| Alere i Influenza A & B 2, Alere i Instrument, Alere i Influenza A & B Control Swab Kit (K171792) | Alere Scarborough, Inc. | 2017-09-29 |