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.

Abbott Diagnostics Scarborough, Inc. 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 | SafeCheck