Medical device recalls Moderate risk

Abbott Diagnostics Scarborough, Inc. recalls Brand Name: ID NOW RSV 24T Product Name: ID NOW RSV 24T Model/Catalog Number: 435-000 Software Version: N/A Product Des…

Recall date
March 4, 2025
Source
U.S. Food & Drug Administration (FDA) — enforcement report
Recall number
Z-1576-2025
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 RSV 24T Product Name: ID NOW RSV 24T Model/Catalog Number: 435-000 Software Version: N/A Product Description: Respiratory virus panel nucleic acid assay system Component: No

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