Device recall
Z-2131-2011: Synchron LX20 PRO, Part Number: 476100. Designed for the in vitro determination…
FDA device recall · Class I · Beckman Coulter Inc.
Key facts
| Recall number (Z-number) | Z-2131-2011 |
|---|---|
| Recall event | 58567 |
| Product | Synchron LX20 PRO, Part Number: 476100. Designed for the in vitro determination of a variety of general chemistries, therapeutic drugs, and other chemistries. |
| Product code | JJE |
| Recalling firm | Beckman Coulter Inc. |
| Recall class | Class I |
| Status | Terminated |
| Termination date | Feb 6, 2013 |
| 510(k) numbers | K011213 |
| FEI number | 2050012 |
At a glance
- 1–9 Linked 510(k)s
- 1–9 Products in the same recall event
- 100–999 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