Device recall
Z-0891-2022: ARCHITECT STAT Myoglobin Calibrators, RES 2K43-01 The ARCHITECT STAT Myoglobin…
FDA device recall · Class II · Abbott Laboratories
Key facts
| Recall number (Z-number) | Z-0891-2022 |
|---|---|
| Recall event | 89794 |
| Product | ARCHITECT STAT Myoglobin Calibrators, RES 2K43-01 The ARCHITECT STAT Myoglobin Calibrators are for the calibration of the ARCHITECT iSystem with STAT protocol capability when used for the quantitative determination of myoglobin in human serum and plasma. |
| Product code | JIS |
| Recalling firm | Abbott Laboratories |
| Recall class | Class II |
| Status | Open, Classified |
| 510(k) numbers | K042924 |
| 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