Device recall
Z-0921-2010: IMMAGE Immunochemistry Systems C-Reactive Protein (CRP) Reagent, Part Number…
FDA device recall · Class III · Beckman Coulter Inc
Key facts
| Recall number (Z-number) | Z-0921-2010 |
|---|---|
| Recall event | 48648 |
| Product | IMMAGE Immunochemistry Systems C-Reactive Protein (CRP) Reagent, Part Number 447280. Intended for the quantitative determination of C-Reactive Protein (CRP) in human serum or plasma by rate nephelometry. |
| Product code | DCK |
| Recalling firm | Beckman Coulter Inc |
| Recall class | Class III |
| Status | Terminated |
| Termination date | Jul 2, 2012 |
| 510(k) numbers | K981638 |
| 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