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-1573-2025

FDA classification

Class II

Brand / firm

Abbott Diagnostics Scarborough, Inc.

Sold / distributed

Worldwide distribution - US Nationwide and the countries of Australia; Austria; Belgium; Bulgaria; Canada; Costa Rica; France; French Polynesia; Germany; Italy; Luxembourg; Malaysia; Netherlands; Paraguay; Poland; Qatar; Saudi Arabia; Slovenia; South Korea; Spain; Switzerland; Taiwan; United Kingdo…

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