[pending] Product Name: ID NOW" Influenza A & B 2 Model/Catalog Number: 427-000 Software Version: Not Applic
Pending LLM rewrite. Source: FDA_DEVICE Z-1565-2026.
What this means for you
Real risk of harm even if no illness or injury has been reported yet. Stop using the product and follow the agency's guidance.
Our severity reasoning: Pending LLM scoring against the rubric.
Plain-English summary
It was confirmed that the impacted lot has a higher occurrence of invalid rates when compared to the product Instructions for Use.
The recalled product
- 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
- Manufacturer
- Abbott Diagnostics Scarborough, Inc.
- Category
- Medical Device — Devices
Is your product affected?
Check your packaging against the codes below. If any of them match, the product is part of this recall.
Lot numbers (4)
- List Number: 427-000
- UDI-DI: 10811877010422
- Lot Number: 000X133126
- Expiry: 2027 02 21
Distribution
Distributed nationwide across the United States.
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