Device recall
Z-0443-2011: Cholestech LDX Calibration Verification, Levels 1-4, Catalog Number 11-255. To…
FDA device recall · Class II · Biosite Inc Dba Innovacon Inc.
Key facts
| Recall number (Z-number) | Z-0443-2011 |
|---|---|
| Recall event | 56985 |
| Product | Cholestech LDX Calibration Verification, Levels 1-4, Catalog Number 11-255. To be used for verifying the reportable range of tests on the Cholestech LDX System. |
| Product code | JJY |
| Recalling firm | Biosite Inc Dba Innovacon Inc. |
| Recall class | Class II |
| Status | Terminated |
| Termination date | Aug 1, 2012 |
| 510(k) numbers | K913687 |
| FEI number | 1000125596 |
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