Device recall
Z-2110-2010: RQCHRT HRT Control Level 1 & 2; Whole Blood controls for use with Hemochron…
FDA device recall · Class II · International Technidyne Corp.
Key facts
| Recall number (Z-number) | Z-2110-2010 |
|---|---|
| Recall event | 56114 |
| Product | RQCHRT HRT Control Level 1 & 2; Whole Blood controls for use with Hemochron Kaolin and Celite HRT Test Tubes. 20 vials Whole Blood - 2.0mL; dried 20 vials Diluent - 4.0 mL The Hemochron HRT Whole Blood Quality Controls are intended to be used to perform quality control assays using the Hemochron HRT… |
| Product code | KFF |
| Recalling firm | International Technidyne Corp. |
| Recall class | Class II |
| Status | Terminated |
| Termination date | Sep 23, 2010 |
| 510(k) numbers | K904003 |
| 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