Medical device recalls Moderate risk

Abbott Diagnostics Scarborough, Inc. recalls Product Name: ID NOW" Influenza A & B 2 Model/Catalog Number: 427-000 Software Version: Not Applicable Product Descript…

Recall date
February 9, 2026
Source
U.S. Food & Drug Administration (FDA) — enforcement report
Recall number
Z-1565-2026
FDA classification
Class II
Brand / firm
Abbott Diagnostics Scarborough, Inc.
Sold / distributed
US Nationwide distribution.

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.

Class II means using this product may cause temporary or medically reversible health problems; the chance of serious harm is remote.

What was recalled

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

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