Recall Z-1565-2026— Abbott Diagnostics Scarborough, Inc.

Name: FDA recall Z-1565-2026
Creator: U.S. Food and Drug Administration
Published: 2026-02-09

Class II · Ongoing

Class II FDA medical device recall by Abbott Diagnostics Scarborough, Inc., initiated 2026-02-09. It names one FDA 510(k) clearance: K171792. 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. Reason: It was confirmed that the impacted lot has a higher occurrence of invalid rates when compared to the product Instructions for Use..

Recalling firm: Abbott Diagnostics Scarborough, Inc.
Classification: Class II
Status: Ongoing
Initiated: 2026-02-09
Firm location: Scarborough, ME, United States

510(k) clearances named in this recall

1 on FDA's record

K171792 — Alere i Influenza A & B 2, Alere i Instrument, Alere i Influenza A & B Control Swab KitAlere Scarborough, Inc.·cleared 2017-09-29

K-numbers as listed on FDA's Recall Enterprise System record for this event (openFDA device/recall k_numbers). The recall may also cover devices cleared under other submissions not named here.

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

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.

Data sourced from openFDA. This site is unofficial and independent of the FDA.