Class II

Medical Device Recall: 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

Abbott Diagnostics Scarborough, Inc. · March 4, 2025

Reason for Recall

The impacted lots have a higher occurrence of invalid rates when compared to the product Instructions for Use.

Distribution

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 Kingdom; Uruguay.

States Affected

NATIONWIDE

Quantity Affected

178056 eaches (147472 US, 31584 OUS)

Source: FDA (openFDA Device Enforcement)

Recall number: Z-1573-2025

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.