FDA-Device2025-04-23Class II
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
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
2,776,416 eaches
Manufactured in
10 Southgate Rd, Scarborough, ME, United States
Products
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
Official notice
https://www.accessdata.fda.gov/scripts/ires/index.cfm?Product=Z-1575-2025Don't want to check this manually?
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