Device recall
Z-1033-2015: DrugCheck Ketamine Dip Test 31317-3P PRO-EU-SWE, 31226-3-CA-GML, 30842 TR…
FDA device recall · Class II · Express Diagnostics Int'l., Inc.
Key facts
| Recall number (Z-number) | Z-1033-2015 |
|---|---|
| Recall event | 70008 |
| Product | DrugCheck Ketamine Dip Test 31317-3P PRO-EU-SWE, 31226-3-CA-GML, 30842 TR, 30108C, 30108C CAN, 30108C EU, and 30108C INT. This assay provides only a preliminary analytical test result. |
| Product code | MGX |
| Recalling firm | Express Diagnostics Int'l., Inc. |
| Recall class | Class II |
| Status | Terminated |
| Termination date | May 14, 2019 |
| FEI number | 3014946040 |
At a glance
- None 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