Device recall
Z-2238-2009: SYNCHRON Systems Salicylate (SALY) Reagent; Part Number: 378194. SALY reagent…
FDA device recall · Class II · Beckman Coulter Inc
Key facts
| Recall number (Z-number) | Z-2238-2009 |
|---|---|
| Recall event | 48191 |
| Product | SYNCHRON Systems Salicylate (SALY) Reagent; Part Number: 378194. SALY reagent, when used in conjunction with SUNCHRON LX System(s), UniCel DxC 600/800 Systems(s), SYNCHRON CX Systems(s) and SYNCHRON Systems Salicylate Calibrator, is intended for the quantitative determination of Salicylate… |
| Product code | DKJ |
| Recalling firm | Beckman Coulter Inc |
| Recall class | Class II |
| Status | Terminated |
| Termination date | Jul 16, 2012 |
| 510(k) numbers | K014173 |
| 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