Device recall
Z-2051-2013: SARKEN STAT! 1- Panel Test Kit-COC Product Usage- Labeled as FOR FORENSIC USE…
FDA device recall · Class II · Sarken, Inc.
Key facts
| Recall number (Z-number) | Z-2051-2013 |
|---|---|
| Recall event | 65841 |
| Product | SARKEN STAT! 1- Panel Test Kit-COC Product Usage- Labeled as FOR FORENSIC USE ONLY (Employee, Student or Probation Testing). |
| Product code | DIO |
| Recalling firm | Sarken, Inc. |
| Recall class | Class II |
| Status | Terminated |
| Termination date | Jul 16, 2014 |
| FEI number | 3000297792 |
At a glance
- None 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