Device recall
Z-0400-06: ARCHITECT STAT Myoglobin Calibrators; list 02K43-01; each kit contains 6 bottles…
FDA device recall · Class III · Abbott Laboratories MPG
Key facts
| Recall number (Z-number) | Z-0400-06 |
|---|---|
| Recall event | 33845 |
| Product | ARCHITECT STAT Myoglobin Calibrators; list 02K43-01; each kit contains 6 bottles of calibrators ranging from 0 ng/mL to 1200 ng/mL; Abbott Laboratories, Diagnostics Division, Abbott Park, IL 60064 |
| Product code | DDR |
| Recalling firm | Abbott Laboratories MPG |
| Recall class | Class III |
| Status | Terminated |
| Termination date | May 25, 2006 |
| 510(k) numbers | K042920 |
| 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