Device recall
Z-1130-2012: Product Brand Names: Triage Drugs of Abuse Panel 8 Test Kit (K924476), Triage…
FDA device recall · Class II · Alere San Diego
Key facts
| Recall number (Z-number) | Z-1130-2012 |
|---|---|
| Recall event | 60980 |
| Product | Product Brand Names: Triage Drugs of Abuse Panel 8 Test Kit (K924476), Triage Drugs of Abuse Panel Plus TCA (K973784), & Triage Drugs of Abuse Panel Plus PPX (K014247) Model Number: 90008, 92002, & 92000 Type of Packaging (i.e. box, plastic bag): For all affected device types: 25 individually… |
| Product code | DIS |
| Recalling firm | Alere San Diego |
| Recall class | Class II |
| Status | Terminated |
| Termination date | Jul 5, 2013 |
| 510(k) numbers | K014247, K924476, K973784 |
| FEI number | 1000125596 |
At a glance
- 1–9 Linked 510(k)s
- 1–9 Products in the same recall event
- 1–9 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