Recall Z-1565-2026 ยท OZE Influenza A And Influenza B Multiplex Nucleic Acid Assay
Abbott Diagnostics Scarborough, Inc.
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
| Date | Mar 13, 2026 (initiated Feb 9, 2026) |
| Status | Open, Classified |
| Reason | It was confirmed that the impacted lot has a higher occurrence of invalid rates when compared to the product Instructions for Use. |
| Root cause | Under Investigation by firm |
| Action | 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. " Ret |
| Quantity | 111984 units |
| Distribution | US Nationwide distribution. |
| FDA record | Open on fda.gov |
510(k) clearances named in this recall
| K171792 | Alere i Influenza A & B 2, Alere i Instrument, Alere i Influenza A & B Control Swab Kit Alere Scarborough, Inc., Sep 29, 2017 |