FDA recall Z-1565-2026

Abbott Diagnostics Scarborough, Inc. · Class II · 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

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.

Distribution

US Nationwide distribution.

Key facts

Status
Ongoing
Initiation date
2026-02-09
Report date
2026-03-25
Voluntary/Mandated
Voluntary: Firm initiated
Location
Scarborough, ME, United States

Primary source

https://www.accessdata.fda.gov/scripts/ires/index.cfm?Product=Z-1565-2026