Device recall
Z-1358-2019: ARCHITECT Intact PTH Calibrators - Product Usage: The ARCHITECT Intact PTH…
FDA device recall · Class III · Abbott Laboratories
Key facts
| Recall number (Z-number) | Z-1358-2019 |
|---|---|
| Recall event | 82590 |
| Product | ARCHITECT Intact PTH Calibrators - Product Usage: The ARCHITECT Intact PTH Calibrators are for the calibration of the ARCHITECT iSystem when used for the quantitative determination of Intact PTH in human serum and plasma. |
| Product code | JIT |
| Recalling firm | Abbott Laboratories |
| Recall class | Class III |
| Status | Terminated |
| Termination date | Dec 20, 2019 |
| 510(k) numbers | K063232 |
| 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