Device recall
Z-1093-2011: Hemochron Whole Blood Coagulation Systems Activated Clotting Time (ACT); Package…
FDA device recall · Class II · International Technidyne Corp.
Key facts
| Recall number (Z-number) | Z-1093-2011 |
|---|---|
| Recall event | 57405 |
| Product | Hemochron Whole Blood Coagulation Systems Activated Clotting Time (ACT); Package label states -International Technidyne Corporation Response Celite ACT Tube HRFTCA510; Lot number and expiration date are listed. Each box contains 95 ACT tubes tests. Used for heparin anticoagulation monitoring during… |
| Product code | KQG |
| Recalling firm | International Technidyne Corp. |
| Recall class | Class II |
| Status | Terminated |
| Termination date | Aug 22, 2012 |
| 510(k) numbers | K983475 |
| FEI number | 1000526865 |
At a glance
- 1–9 Linked 510(k)s
- 1–9 Products in the same recall event
- 1–9 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