FDA-Device2026-03-25Class II
Product Name: ID NOW" Influenza A & B 2 Model/Catalog Number: 427-000 Software Version: Not Applicable Product Description: Influenza A/B virus nucleic acid IVD, kit, nucleic acid technique Component: Not Applicable
Abbott Diagnostics Scarborough, Inc.
Hazard
It was confirmed that the impacted lot has a higher occurrence of invalid rates when compared to the product Instructions for Use.
Sold states
US Nationwide distribution.
Affected count
111984 units
Manufactured in
10 Southgate Rd, N/A, Scarborough, ME, United States
Products
Product Name: ID NOW" Influenza A & B 2 Model/Catalog Number: 427-000 Software Version: Not Applicable Product Description: Influenza A/B virus nucleic acid IVD, kit, nucleic acid technique Component: Not Applicable
Official notice
https://www.accessdata.fda.gov/scripts/ires/index.cfm?Product=Z-1565-2026Original summary
Product Name: ID NOW" Influenza A & B 2 Model/Catalog Number: 427-000 Software Version: Not Applicable Product Description: Influenza A/B virus nucleic acid IVD, kit, nucleic acid technique Component: Not Applicable It was confirmed that the impacted lot has a higher occurrence of invalid rates when compared to the product Instructions for Use. List Number: 427-000; UDI-DI: 10811877010422; Lot Number: 000X133126; Expiry: 2027 02 21; Distribution: US Nationwide distribution. Affected quantity: 111984 units
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