Device recall
Z-2148-2008: Equal Diagnostics Lipase Color Reagent Kit Part Number: 905-B For In Vitro…
FDA device recall · Class III · Genzyme Corporation
Key facts
| Recall number (Z-number) | Z-2148-2008 |
|---|---|
| Recall event | 48184 |
| Product | Equal Diagnostics Lipase Color Reagent Kit Part Number: 905-B For In Vitro Diagnostic Use Containing the Lipase Color Reagent, 30 ml, Part Number 80-2005-01. |
| Product code | CHI |
| Recalling firm | Genzyme Corporation |
| Recall class | Class III |
| Status | Terminated |
| Termination date | Sep 16, 2008 |
| 510(k) numbers | K897150 |
| FEI number | 1221955 |
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