Recalling firm
Abbott Diagnostics Scarborough, Inc.
Product type
Device
Status
Ongoing
Report date
2026-03-25
Distribution
US Nationwide distribution.
Firm state
ME
Product quantity
111984 units
Initiated by
Voluntary: Firm initiated
Reason for recall
It was confirmed that the impacted lot has a higher occurrence of invalid rates when compared to the product Instructions for Use.
Product description
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
Code / lot info
List Number: 427-000; UDI-DI: 10811877010422; Lot Number: 000X133126; Expiry: 2027 02 21;
Data: U.S. FDA openFDA enforcement API. Recall details are as reported by the FDA. The quality-domain mapping and severity are a SPEQ editorial interpretation of the recall reason, not an official FDA classification.