FDA DevicesClass II
Product Name: ID NOW" Influenza A & B 2 Model/Catalog Number: 427-000 Software...
Published: March 25, 2026Recall ID: Z-1565-2026Category: devicesCountry: US
Reason for Recall / Hazard
It was confirmed that the impacted lot has a higher occurrence of invalid rates when compared to the product Instructions for Use.
Product Description & Identification
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
Affected Products
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
Additional Source Details
| Field | Value |
|---|---|
| City | Scarborough |
| State | ME |
| Event id | 98400 |
| Address 1 | 10 Southgate Rd |
| Address 2 | N/A |
| Code info | List Number: 427-000; UDI-DI: 10811877010422; Lot Number: 000X133126; Expiry: 2027 02 21; |
| Postal code | 04074-8303 |
| Report date | 20260325 |
| Product type | Devices |
| Product quantity | 111984 units |
| 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. |
| Voluntary mandated | Voluntary: Firm initiated |
| Recall initiation date | 20260209 |
| Initial firm notification | Two or more of the following: Email, Fax, Letter, Press Release, Telephone, Visit |
| Center classification date | 20260313 |
Overview
- Recalling FirmAbbott Diagnostics Scarborough, Inc.
- StatusOngoing
- Risk LevelClass II
- DistributionUS Nationwide distribution.