Device recall
Z-1565-2026: Product Name: ID NOW" Influenza A & B 2 Model/Catalog Number: 427-000 Software…
FDA device recall · Class II · Abbott Diagnostics Scarborough, Inc.
Key facts
| Recall number (Z-number) | Z-1565-2026 |
|---|---|
| Recall event | 98400 |
| 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 |
| Product code | OZE |
| Recalling firm | Abbott Diagnostics Scarborough, Inc. |
| Recall class | Class II |
| Status | Open, Classified |
| 510(k) numbers | K171792 |
| FEI number | 1221359 |
At a glance
- 1–9 Linked 510(k)s
- 1–9 Products in the same recall event
- 1–9 Recalled products with this product code
Counts are shown as ranges. Exact figures, trends and every underlying record are available in Orca1.
About FDA device recalls (products)
Each recalled device product receives a Z-number. Recall details such as root cause, distribution and firm actions are available in Orca1.
Source: U.S. Food and Drug Administration (FDA), Medical Device Recalls database