Device recall
Z-0521-2012: Triage Drugs of Abuse Panel Plus TCA 25 Test Kit, PN (Model Number) 92000 An…
FDA device recall · Class II · Alere San Diego
Key facts
| Recall number (Z-number) | Z-0521-2012 |
|---|---|
| Recall event | 60519 |
| Product | Triage Drugs of Abuse Panel Plus TCA 25 Test Kit, PN (Model Number) 92000 An immunoassay used for the qualitative determination of the presence of the major metabolites of drugs of abuse and Tricyclic Antidepressants in urine. |
| Product code | DKZ |
| Recalling firm | Alere San Diego |
| Recall class | Class II |
| Status | Terminated |
| Termination date | Apr 4, 2012 |
| 510(k) numbers | K973784 |
| 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