Device recall
Z-1081-04: STA Heparin Control kit used on STA analyzers (STA, STA Compact, STAR). The STA…
FDA device recall · Class III · Diagnostica Stago, Inc.
Key facts
| Recall number (Z-number) | Z-1081-04 |
|---|---|
| Recall event | 29169 |
| Product | STA Heparin Control kit used on STA analyzers (STA, STA Compact, STAR). The STA heparin control kit is a set of two plasmas containing different levels of unfractionated heparin (UFH) intended for the quality control of UFH assays performed on STA analyzers. Each kit contains 6 x 1 mL vials of… |
| Product code | JOX |
| 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
- 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