Abbott Diagnostics Scarborough, Inc.: Product Name: ID NOW" Influenza A & B 2 Model/Catalog Number: 427-000 Software Version: Not Applicable Product Description: Influenza A/B
Read the official notice at FDA (device) →
The text below is copied from the official FDA (device) record. If anything differs, the official notice is correct.
- Company / brand
- Abbott Diagnostics Scarborough, Inc.
- 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 / hazard
- It was confirmed that the impacted lot has a higher occurrence of invalid rates when compared to the product Instructions for Use.
- Classification
- Class II
- Status
- Ongoing
- Distribution / sold at
- US Nationwide distribution.
- Recall initiated
- 2026-02-09
- Code info
- List Number: 427-000; UDI-DI: 10811877010422; Lot Number: 000X133126; Expiry: 2027 02 21;
- Product quantity
- 111984 units
- Voluntary mandated
- Voluntary: Firm initiated
- City
- Scarborough
- State
- ME
- Country
- United States
- Event id
- 98400
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