Device recall
Z-1932-2015: ICT Serum Calibrator REF 146-03. For use in the calibration of the serum Sodium…
FDA device recall · Class II · Abbott Laboratories
Key facts
| Recall number (Z-number) | Z-1932-2015 |
|---|---|
| Recall event | 71302 |
| Product | ICT Serum Calibrator REF 146-03. For use in the calibration of the serum Sodium, Potassium, and Chloride assays. |
| Product code | CEM |
| Recalling firm | Abbott Laboratories |
| Recall class | Class II |
| Status | Terminated |
| Termination date | Jul 21, 2015 |
| 510(k) numbers | K980367 |
| FEI number | 1415939 |
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