Device recall
Z-2326-2009: DCL (Diagnostic Chemicals Limited) Creatine Enzyme Reagent (R2) Catalog Number…
FDA device recall · Class II · Diagnostic Chemicals, Ltd.
Key facts
| Recall number (Z-number) | Z-2326-2009 |
|---|---|
| Recall event | 51156 |
| Product | DCL (Diagnostic Chemicals Limited) Creatine Enzyme Reagent (R2) Catalog Number: 265-30. In-vitro diagnostic device used for the quantitative measurement of creatine in serum, plasma and urine. |
| Product code | JFY |
| Recalling firm | Diagnostic Chemicals, Ltd. |
| Recall class | Class II |
| Status | Terminated |
| Termination date | May 23, 2012 |
| 510(k) numbers | K070383 |
| 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