Device recall
Z-1993-2025: STA - Owren Koller. Model/Catalog Number: 00360 STA - Owren-Koller is a buffer…
FDA device recall · Class II · Diagnostica Stago, Inc.
Key facts
| Recall number (Z-number) | Z-1993-2025 |
|---|---|
| Recall event | 96937 |
| Product | STA - Owren Koller. Model/Catalog Number: 00360 STA - Owren-Koller is a buffer solution intended for use as a diluent for reagents and human plasmas in coagulation tests performed with analyzers of the STA-R, STA Compact, STA Satellite and ST art families. |
| Product code | PPM |
| Recalling firm | Diagnostica Stago, Inc. |
| Recall class | Class II |
| Status | Open, Classified |
| 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