Class IIReported 2026-03-25
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
Recalled by Abbott Diagnostics Scarborough, Inc.
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.
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Recall NumberZ-1565-2026ClassificationClass IIStatusOngoingCategorydeviceInitiated2026-02-09Reported2026-03-25DistributionUS Nationwide distribution.Code InfoList Number: 427-000; UDI-DI: 10811877010422; Lot Number: 000X133126; Expiry: 2027 02 21;Source: openFDA enforcement report. WhichRecall is not affiliated with the FDA. See our disclaimer.