Device recall
Z-1432-2012: SYNCHRON Ammonia (AMM) Reagent Product Usage: AMM reagent, when used in…
FDA device recall · Class II · Beckman Coulter Inc.
Key facts
| Recall number (Z-number) | Z-1432-2012 |
|---|---|
| Recall event | 53049 |
| Product | SYNCHRON Ammonia (AMM) Reagent Product Usage: AMM reagent, when used in conjunction with SYNCHRON LX System(s), UniCel DxC 600/800 System(s) and SYNCHRON Systems Ammonia Calibrators, is intended for the quantitative determination of Ammonia concentration in human plasma. |
| Product code | JIF |
| Recalling firm | Beckman Coulter Inc. |
| Recall class | Class II |
| Status | Terminated |
| Termination date | Apr 18, 2012 |
| 510(k) numbers | K984402 |
| 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