Device recall
Z-0837-2013: Pro Time Microcoagulation System/ Pro Time 3 Cuvette, Pro3-4, Pro3-25, and…
FDA device recall · Class II · International Technidyne Corp.
Key facts
| Recall number (Z-number) | Z-0837-2013 |
|---|---|
| Recall event | 64076 |
| Product | Pro Time Microcoagulation System/ Pro Time 3 Cuvette, Pro3-4, Pro3-25, and Pro3-50. International Technidyne Corporation. The Pro Time Microcoagulation System is a portable battery operated instrument with a disposable cuvette for quantitative determination of prothrombin time from fingerstick whole… |
| Product code | GJS |
| Recalling firm | International Technidyne Corp. |
| Recall class | Class II |
| Status | Terminated |
| Termination date | Jan 9, 2014 |
| 510(k) numbers | K010599 |
| FEI number | 1000526865 |
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