Device recall
Z-1229-2012: Synchron CX Immuno-Protein Cal, part number: 442840, other product code: CKA The…
FDA device recall · Class II · Beckman Coulter Inc.
Key facts
| Recall number (Z-number) | Z-1229-2012 |
|---|---|
| Recall event | 61122 |
| Product | Synchron CX Immuno-Protein Cal, part number: 442840, other product code: CKA The Beckman Coulter SYNCHRON CX Immune Protein Calibrator Set, in conjunction with SYNCHRON Immuno Protein Reagents, is intended for use on SYNCHRON CX Systems for the calibration of IgA, IgG, IgM, and Transferrin (TRF). |
| Product code | JIT |
| Recalling firm | Beckman Coulter Inc. |
| Recall class | Class II |
| Status | Terminated |
| Termination date | Apr 17, 2012 |
| 510(k) numbers | K883181 |
| 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