Abbott Diagnostics Scarborough, Inc. recalls Product Name: ID NOW" Influenza A & B 2 Model/Catalog Number: 427-000 Software Versio…

It was confirmed that the impacted lot has a higher occurrence of invalid rates when compared to the product Instructions for Use.

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

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.

• FDA enforcement recordOfficial FDA database entry for Z-1565-2026
• FDA 510(k) clearance · K171792The device's official FDA premarket clearance record
• FDA device classification · OZEOfficial FDA classification for this device type
• CFR regulation · 21 CFR 866.3980The federal regulation governing this device
• FDA recall announcementSearch FDA.gov for the official press announcement
• Find Abbott Diagnostics Scarborough, Inc.Search for the manufacturer's official notice
• News coverageRecent reporting on this recall and manufacturer
• openFDA data recordThe raw JSON record this page is built from

Source: U.S. FDA openFDA device enforcement reports. This summary is informational and may lag or differ from the official record. Always verify against the FDA before acting.