FDA Medical devices recall ·
ID NOW" Influenza A & B 2 Model recall
- Recall number
- Z-1565-2026
- Date
- (initiated February 9, 2026)
- Company / brand
- Abbott Diagnostics Scarborough, Inc.
10 Southgate Rd, Scarborough, ME, United States - Category
- Medical devices › Class II
- Classification
- Class II
- Status
- Ongoing
- Units affected
- 111984 units
- Initiated by
- Voluntary: Firm initiated
Read the official FDA notice ↗
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
Why was it recalled?
It was confirmed that the impacted lot has a higher occurrence of invalid rates when compared to the product Instructions for Use.
What should you do?
FDA enforcement reports do not list a consumer remedy. Check the product codes below against what you have; if it matches, stop using it and follow the instructions in the firm's or FDA's official notice, or contact the company. If you have health concerns, contact your healthcare provider.
Product codes & lot numbers
List Number: 427-000; UDI-DI: 10811877010422; Lot Number: 000X133126; Expiry: 2027 02 21;
Distribution
US Nationwide distribution.
What does Class II mean?
Class II means use of or exposure to the product may cause temporary or medically reversible adverse health consequences, or the probability of serious harm is remote.
Source: FDA (medical devices), recall Z-1565-2026. Official notice. Republished from public data; RecallFlag is not affiliated with the FDA.