FDA-Device2025-04-23Class II
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.
Hazard
the impacted lots have a higher occurrence of invalid rates when compared to the product Instructions for Use.
Sold states
US Nationwide distribution.
Affected count
442,296 eaches
Manufactured in
10 Southgate Rd, Scarborough, ME, United States
Products
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
Official notice
https://www.accessdata.fda.gov/scripts/ires/index.cfm?Product=Z-1576-2025Don't want to check this manually?
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