Device recall
Z-0749-2022: Alinity s System software version2.8.0, REF LN 06P16-01, IVD, OEI…
FDA device recall · Class II · Abbott Laboratories, Inc
Key facts
| Recall number (Z-number) | Z-0749-2022 |
|---|---|
| Recall event | 89604 |
| Product | Alinity s System software version2.8.0, REF LN 06P16-01, IVD, OEI: (01)00380740138479 The Alinity s System is intended for In Vitro diagnostic use only. The Alinity s System is a highthroughput, fully automated immunoassay analyzer designed to determine the presence of specific antigens and… |
| Product code | MZA |
| Recalling firm | Abbott Laboratories, Inc |
| Recall class | Class II |
| Status | Open, Classified |
| FEI number | 1628664 |
At a glance
- None 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