Device recall
Z-2402-2011: Cholestech LDX Lipid Profile"GLU test cassettes, Catalog Number 10-991, Lot #…
FDA device recall · Class II · Biosite Inc Dba Innovacon Inc.
Key facts
| Recall number (Z-number) | Z-2402-2011 |
|---|---|
| Recall event | 58557 |
| Product | Cholestech LDX Lipid Profile"GLU test cassettes, Catalog Number 10-991, Lot # 245104 Cholestech LDX Lipid-Glucose tests are intended for the quantitative determination of total cholesterol, HDL (high-density lipoprotein) cholesterol, triglycerides, and/or glucose in whole blood, serum, and plasma. A… |
| Product code | CGA |
| Recalling firm | Biosite Inc Dba Innovacon Inc. |
| Recall class | Class II |
| Status | Terminated |
| Termination date | Apr 2, 2012 |
| 510(k) numbers | K904082 |
| 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