Device recall
Z-2247-2016: The Synchron Systems No Foam DxC (Reference No. B64130) affects the UniCel DxC…
FDA device recall · Class II · Beckman Coulter Inc.
Key facts
| Recall number (Z-number) | Z-2247-2016 |
|---|---|
| Recall event | 74559 |
| Product | The Synchron Systems No Foam DxC (Reference No. B64130) affects the UniCel DxC System (chemistry analyzer). All lots of No Foam DxC reagent are affected by this recall. |
| Product code | LDT |
| Recalling firm | Beckman Coulter Inc. |
| Recall class | Class II |
| Status | Terminated |
| Termination date | Aug 25, 2017 |
| FEI number | 2050012 |
At a glance
- None 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