Product Name: ID NOW" Influenza A & B 2 recallZ-1565-2026 · Abbott Diagnostics Scarborough, Inc. · initiated Feb 9, 2026
Open, Classified
Is my device affected?
- Compare the model, catalog and lot or serial numbers on your device or its packaging with the code information below. A recall usually covers only specific models or lots.
- If yours is listed, follow the instructions from Abbott Diagnostics Scarborough, Inc. or your healthcare provider. The company's action is summarized under what the company is doing.
- Do not stop using a prescribed or implanted device on your own — talk to your healthcare provider first.
Where to find your model and lot numbers · What recall classes and statuses mean
Why it was recalled
It was confirmed that the impacted lot has a higher occurrence of invalid rates when compared to the product Instructions for Use.
FDA root cause category: Under Investigation by firm
What the company is doing
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.
Recall details
- Recall number
- Z-1565-2026
- Status
- Open, Classified
- Initiated by the company
- Feb 9, 2026
- Posted by the FDA
- Mar 13, 2026
- Recalling firm
- Abbott Diagnostics Scarborough, Inc.
- Quantity
- 111984 units
- Product code
- OZE
- FDA submissions
- K171792
- Distribution
- US Nationwide distribution.
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
Code information (models, lots, serial numbers)
List Number: 427-000; UDI-DI: 10811877010422; Lot Number: 000X133126; Expiry: 2027 02 21;
Devices named in this recall
1 device in the FDA device registry whose identifier appears in the recall's code information.
- ID NOW Influenza A & B 2 427-000Alere Scarborough, Inc. · Devices Detecting Influenza A, B, And C Virus Antigens3 recalls2 reports
Sources and updates
- Recall record: FDA Medical Device Recalls, file dated Oct 16, 2026 · View the FDA recall notice ↗
- Devices: FDA GUDID, file dated Oct 13, 2026. Devices are linked when their identifier (with a valid check digit) appears in the recall's code information.
- Page last rebuilt: Oct 16, 2026. Text above is shown as published by the FDA.
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