Device recall
Z-2460-2008: Cholestech GDX A1C Test Cartridge. The Cholestech GDX A1C Test is an in-vitro…
FDA device recall · Class II · Cholestech Corp
Key facts
| Recall number (Z-number) | Z-2460-2008 |
|---|---|
| Recall event | 49359 |
| Product | Cholestech GDX A1C Test Cartridge. The Cholestech GDX A1C Test is an in-vitro diagnostic test that measures hemoglobin A1c (HbA1c). |
| Product code | LCP |
| Recalling firm | Cholestech Corp |
| Recall class | Class II |
| Status | Terminated |
| Termination date | Oct 7, 2009 |
| 510(k) numbers | K041635 |
| FEI number | 1000123985 |
At a glance
- 1–9 Linked 510(k)s
- 1–9 Products in the same recall event
- 100–999 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