Device recall
Z-2650-2014: Stago IVD, Liquid Anti-Xa, NDC 3607450003116. The STA - Liquid Anti-Xa kits are…
FDA device recall · Class III · Diagnostica Stago, Inc.
Key facts
| Recall number (Z-number) | Z-2650-2014 |
|---|---|
| Recall event | 69070 |
| Product | Stago IVD, Liquid Anti-Xa, NDC 3607450003116. The STA - Liquid Anti-Xa kits are intended for use with STA-R, STA Compact and STA Satellite Analyzers for the quantitative determination of the plasma levels of unfractionated (UFH) and low molecular weight (LMWH) heparins by measuring their anti-Xa… |
| Product code | KFF |
| Recalling firm | Diagnostica Stago, Inc. |
| Recall class | Class III |
| Status | Terminated |
| Termination date | Jan 16, 2015 |
| 510(k) numbers | K111822 |
| FEI number | 2245451 |
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