Device recall
Z-1396-2009: Access Myoglobin Reagents Kits, Part Number: 973243. The Access Myoglobin assay…
FDA device recall · Class III · Beckman Coulter Inc
Key facts
| Recall number (Z-number) | Z-1396-2009 |
|---|---|
| Recall event | 48692 |
| Product | Access Myoglobin Reagents Kits, Part Number: 973243. The Access Myoglobin assay is a paramagnetic particle, chemiluminescent immunoassay for the quantitative determination of Myoglobin levels in human serum and plasma using the Access Immunoassay Systems. |
| Product code | DDR |
| Recalling firm | Beckman Coulter Inc |
| Recall class | Class III |
| Status | Terminated |
| Termination date | May 27, 2009 |
| 510(k) numbers | K021229 |
| FEI number | 2050012 |
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