Device recall
Z-2276-2021: Alinity s System REF 06P16-01. An automated immunoassay analyzer for In Vitro…
FDA device recall · Class II · Abbott Laboratories, Inc
Key facts
| Recall number (Z-number) | Z-2276-2021 |
|---|---|
| Recall event | 88324 |
| Product | Alinity s System REF 06P16-01. An automated immunoassay analyzer for In Vitro diagnostic use in blood donor screening, plasma and plasmapheresis screening, and organ donor centers, hospitals, and reference laboratories. |
| 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