FDA Device recall Z-1565-2026
Product Name: ID NOW" Influenza A & B 2 Model/Catalog Number: 427-000 Software Version: Not Applicable Product Description: Influenza A/B v…
- FDA Device
- Class II
- ongoing
- Published 2026-03-25
On 2026-03-25 the FDA classified a Class II recall of Product Name: ID NOW" Influenza A & B 2 Model/Catalog Number: 427-000 Software Version: Not Applicable Product Description: Influenza A/B v… by Abbott Diagnostics Scarborough, citing it was confirmed that the impacted lot has a higher occurrence of invalid rates when compared to the product Instructions for Use.
Read the official FDA Device notice
| Agency | FDA Device |
|---|---|
| Recall number | Z-1565-2026 |
| Classification | Class II |
| Status | ongoing |
| Initiated | 2026-02-09 |
| Published | 2026-03-25 |
| Last updated | 2026-09-13 11:58 UTC |
| Company | Abbott Diagnostics Scarborough |
| Distribution | US |
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
It was confirmed that the impacted lot has a higher occurrence of invalid rates when compared to the product Instructions for Use.
Identifiers
| code_info | List Number: 427-000; UDI-DI: 10811877010422; Lot Number: 000X133126; Expiry: 2027 02 21; |
|---|
Status history
No status changes recorded since RecallRadar first saw this recall on 2026-09-13 11:58 UTC. Current status: ongoing.
Source
Official record: https://api.fda.gov/device/enforcement.json?search=recall_number:%22Z-1565-2026%22
RecallRadar indexes public recall notices from the FDA, USDA FSIS, and CPSC. The official agency notice is the authoritative source. Always confirm details at the linked source before acting.