Class II

Medical Device Recall: 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 Compon

Abbott Diagnostics Scarborough, Inc. · February 9, 2026

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.

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

Distribution

US Nationwide distribution.

States Affected

NATIONWIDE

Quantity Affected

111984 units

Source: FDA (openFDA Device Enforcement)

Recall number: Z-1565-2026

Status: ongoing

SafeCheck provides drug interaction information from FDA-approved product labeling (openFDA). This is for informational purposes only and is not medical advice. Always consult your healthcare provider before making medication decisions.