Device recall
Z-1080-04: FDP Plasma kit provides reagents for the detection and semi-quantitation of…
FDA device recall · Class III · Diagnostica Stago, Inc.
Key facts
| Recall number (Z-number) | Z-1080-04 |
|---|---|
| Recall event | 29178 |
| Product | FDP Plasma kit provides reagents for the detection and semi-quantitation of fibrin/fibrinogen degradation products (FDP) in plasma through the use of latex particles coated with monoclonal antibodies to FDP. The kit contains: 1 x1.3 mL vial of Reagent 1 (Latex), 1 x 20mL bottle of Reagent 2… |
| Product code | DAP |
| Recalling firm | Diagnostica Stago, Inc. |
| Recall class | Class III |
| Status | Terminated |
| Termination date | Jul 14, 2004 |
| FEI number | 2245451 |
At a glance
- None 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