Device recall
Z-0110-2013: Synchron Systems Synchron Calibrator Multi Calibrator Diskettes, Part Number…
FDA device recall · Class III · Beckman Coulter Inc.
Key facts
| Recall number (Z-number) | Z-0110-2013 |
|---|---|
| Recall event | 63130 |
| Product | Synchron Systems Synchron Calibrator Multi Calibrator Diskettes, Part Number 442600. The SYNCHRON MULTI-CALIBRATOR, used in conjunction with SYNCHRON reagents, is intended for use on SYNCHRON Systems for the calibration of Albumin, Blood Urea Nitrogen (Urea), Calcium, Cholesterol, Glucose, Inorganic… |
| Product code | JIX |
| Recalling firm | Beckman Coulter Inc. |
| Recall class | Class III |
| Status | Terminated |
| Termination date | Dec 28, 2012 |
| 510(k) numbers | K110251 |
| 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