Device recall
Z-2108-2010: GEM Check Coag CNTRL Abnormal APTT Whole Blood Controls Package Insert; IVD…
FDA device recall · Class II · International Technidyne Corporation
Key facts
| Recall number (Z-number) | Z-2108-2010 |
|---|---|
| Recall event | 56169 |
| Product | GEM Check Coag CNTRL Abnormal APTT Whole Blood Controls Package Insert; IVD. 06260060100. 15/pk. Manufactured for Instrumentation Laboratory Company, Lexington, MA 02421-3125. Intended to be used to perform quality control assays using GEM test cartridges on the IL GEM PCL/PCL Plus Portable… |
| Product code | GGN |
| Recalling firm | International Technidyne Corporation |
| Recall class | Class II |
| Status | Terminated |
| Termination date | Sep 23, 2010 |
| 510(k) numbers | K944691 |
| FEI number | 3005776351 |
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