Device recall
Z-2774-2011: Beckman Coulter - Manual Inhibin A ELISA Reagent Kit; Part Number DSL-10-28100-4…
FDA device recall · Class II · Beckman Coulter Inc.
Key facts
| Recall number (Z-number) | Z-2774-2011 |
|---|---|
| Recall event | 58720 |
| Product | Beckman Coulter - Manual Inhibin A ELISA Reagent Kit; Part Number DSL-10-28100-4 The Inhibin A enzyme-linked immunosorbent assay (ELISA) kit provides materials for the quantitative measurement of dimeric inhibin A in human serum and plasma. This assay is intended for in vitro diagnostic use as an… |
| Product code | ndr |
| Recalling firm | Beckman Coulter Inc. |
| Recall class | Class II |
| Status | Terminated |
| Termination date | Jul 11, 2012 |
| 510(k) numbers | K002128 |
| 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