Device recall
Z-2953-2011: Hemochron JR. Microcoagulation Systems Prothrombin Time (PT). International…
FDA device recall · Class II · International Technidyne Corp.
Key facts
| Recall number (Z-number) | Z-2953-2011 |
|---|---|
| Recall event | 58043 |
| Product | Hemochron JR. Microcoagulation Systems Prothrombin Time (PT). International Ethidine Corp (ITC)-Nexus Dx. A unitized mlcrocoagulation test intended for use in performing one-stage prothrombin time. |
| Product code | JPA |
| Recalling firm | International Technidyne Corp. |
| Recall class | Class II |
| Status | Terminated |
| Termination date | Nov 2, 2012 |
| 510(k) numbers | K940432, K974799 |
| 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