Device recall
Z-1075-2019: Abbott ARCHITECT Creatine Kinase, IVD, REF 7D63-21.
FDA device recall · Class II · Abbott Laboratories, Inc
Key facts
| Recall number (Z-number) | Z-1075-2019 |
|---|---|
| Recall event | 82116 |
| Product | Abbott ARCHITECT Creatine Kinase, IVD, REF 7D63-21. |
| Product code | CGS |
| Recalling firm | Abbott Laboratories, Inc |
| Recall class | Class II |
| Status | Terminated |
| Termination date | Aug 13, 2020 |
| 510(k) numbers | K983070 |
| FEI number | 1628664 |
At a glance
- 1–9 Linked 510(k)s
- 1–9 Products in the same recall event
- 10–99 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