Skip to content
Recall Observatory FDA recall evidence

Device product

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

Z-1565-2026

February 09, 2026

Class II

Product summary

Firm
Abbott Diagnostics Scarborough, Inc.
Event
Event 98400
Status
Ongoing
Classification
Class II
Quantity
111984 units
Official record key
device-enforcement:Z-1565-2026

Official wording

Reason: It was confirmed that the impacted lot has a higher occurrence of invalid rates when compared to the product Instructions for Use.

Code information: List Number: 427-000; UDI-DI: 10811877010422; Lot Number: 000X133126; Expiry: 2027 02 21;

Distribution pattern: US Nationwide distribution.

Derived failure modes

  • Unknown

    reason.no_named_rule · v1.0.0

    It was confirmed that the impacted lot has a higher occurrence of invalid rates when compared to the product Instructions for Use.