Device recall
Z-2200-2010: International Technidyne Corporation (ITC) directCheck Whole Blood Quality…
FDA device recall · Class II · International Technidyne Corp.
Key facts
| Recall number (Z-number) | Z-2200-2010 |
|---|---|
| Recall event | 56117 |
| Product | International Technidyne Corporation (ITC) directCheck Whole Blood Quality Controls Plasma, Coagulation Control. Catalog number: DCJLR-N; in vitro diagnostic 15 vials For performance of Level 1 quality control ACT-LR test cuvettes on the Hemochron Microcoagulation Systems. |
| Product code | GGN |
| Recalling firm | International Technidyne Corp. |
| Recall class | Class II |
| Status | Terminated |
| Termination date | Sep 23, 2010 |
| 510(k) numbers | K944691 |
| 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