Device recall
Z-1088-2009: Triage Drugs of Abuse Panel, Model Number: 95000. Is an immunoassay test kit…
FDA device recall · Class II · Biosite Inc
Key facts
| Recall number (Z-number) | Z-1088-2009 |
|---|---|
| Recall event | 50689 |
| Product | Triage Drugs of Abuse Panel, Model Number: 95000. Is an immunoassay test kit used for the qualitative determination of the presence of the major metabolites of drugs of abuse in urine. |
| Product code | DKZ |
| Recalling firm | Biosite Inc |
| Recall class | Class II |
| Status | Terminated |
| Termination date | Oct 13, 2011 |
| 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