Device recall
Z-1256-2009: HemoSense INRatio2 Prothrombin Time Monitor, manufactured by HemoSense…
FDA device recall · Class III · HemoSense Inc
Key facts
| Recall number (Z-number) | Z-1256-2009 |
|---|---|
| Recall event | 50695 |
| Product | HemoSense INRatio2 Prothrombin Time Monitor, manufactured by HemoSense Incorporated. The INRatio2 PT Monitoring System is used for the quantitative measurement of Prothrombin Time (PT) in fresh, capillary whole blood. |
| Product code | GJS |
| Recalling firm | HemoSense Inc |
| Recall class | Class III |
| Status | Terminated |
| Termination date | Mar 25, 2011 |
| 510(k) numbers | K072727 |
| FEI number | 3003038758 |
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