Medical device recalls Moderate risk

Abbott Diagnostics Scarborough, Inc. recalls Brand Name: ID NOW Influenza A/B 2 24T Product Name: ID NOW Influenza A/B 2 24T Model/Catalog Number: 427-000 Software…

Recall date
March 4, 2025
Source
U.S. Food & Drug Administration (FDA) — enforcement report
Recall number
Z-1575-2025
FDA classification
Class II
Brand / firm
Abbott Diagnostics Scarborough, Inc.
Sold / distributed
US Nationwide distribution.

Why it was recalled

the impacted lots have 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

Brand Name: ID NOW Influenza A/B 2 24T Product Name: ID NOW Influenza A/B 2 24T Model/Catalog Number: 427-000 Software Version: N/A Product Description: Influenza A And Influenza B Multiplex Nucleic Acid Assay; Real Time Nucleic Acid Component: No

Get recall alerts

Free email alert whenever Abbott Diagnostics Scarborough, Inc. has a new recall — straight from official government data. Unsubscribe anytime.

More recalls from: Abbott Diagnostics Scarborough, Inc.