Device recall
Z-0711-2011: Genzyme Diagnostics Total Serum Cholesterol Kit, IVD Catalog Number: 225-26…
FDA device recall · Class III · Diagnostic Chemicals, Ltd.
Key facts
| Recall number (Z-number) | Z-0711-2011 |
|---|---|
| Recall event | 57230 |
| Product | Genzyme Diagnostics Total Serum Cholesterol Kit, IVD Catalog Number: 225-26 Intended use: For the IN VITRO quantitative measurement of total serum cholesterol in serum. |
| Product code | CHH |
| Recalling firm | Diagnostic Chemicals, Ltd. |
| Recall class | Class III |
| Status | Terminated |
| Termination date | Sep 19, 2011 |
| 510(k) numbers | K842160 |
| FEI number | 3002806809 |
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