Device recall
Z-2267-2013: DRI Cocaine Metabolite Assay, labeled as Multigent Cocaine Assay for Abbott…
FDA device recall · Class II · Microgenics Corp
Key facts
| Recall number (Z-number) | Z-2267-2013 |
|---|---|
| Recall event | 65883 |
| Product | DRI Cocaine Metabolite Assay, labeled as Multigent Cocaine Assay for Abbott Laboratories. 100 ml, IVD Mfg by: Microgenics Corporation, 46360 Fremont Blvd. Fremont, CA 94538 The DRI Cocaine Metabolite Enzyme Immunoassay is a homogeneous enzyme intended for the qualitative and semi-quantitative… |
| Product code | DIO |
| Recalling firm | Microgenics Corp |
| Recall class | Class II |
| Status | Terminated |
| Termination date | Dec 2, 2013 |
| 510(k) numbers | K960187 |
| FEI number | 3010939897 |
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