Device recall
Z-1149-04: IgG Antisera component of the paragon Electrophoresis IFE Antisera Kit, a…
FDA device recall · Class III · Beckman Coulter Inc
Key facts
| Recall number (Z-number) | Z-1149-04 |
|---|---|
| Recall event | 28965 |
| Product | IgG Antisera component of the paragon Electrophoresis IFE Antisera Kit, a subcomponent of the Paragon Electrophoresis System Immunofixation (IFE) kit. Part Numbers: 446360 (250 test kit) 446260 (50 test kit) 444970 (10 test kit) |
| Product code | CFF |
| Recalling firm | Beckman Coulter Inc |
| Recall class | Class III |
| Status | Terminated |
| Termination date | Aug 30, 2004 |
| 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