Device recall
Z-2761-2011: Active Cortisol EIA, 96 Wells, DSL-10-2000 The DSL-10-2000 Active Cortisol…
FDA device recall · Class II · Beckman Coulter Inc.
Key facts
| Recall number (Z-number) | Z-2761-2011 |
|---|---|
| Recall event | 55227 |
| Product | Active Cortisol EIA, 96 Wells, DSL-10-2000 The DSL-10-2000 Active Cortisol Enzyme Immunoassay (EIA) kit provides materials for the quantitative measurement of cortisol in serum, plasma or urine. This assay is intended for in vitro diagnostic use. |
| Product code | CGR |
| Recalling firm | Beckman Coulter Inc. |
| Recall class | Class II |
| Status | Terminated |
| Termination date | Apr 27, 2012 |
| 510(k) numbers | K884689 |
| FEI number | 2050012 |
At a glance
- 1–9 Linked 510(k)s
- 1–9 Products in the same recall event
- 1–9 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