Device recall
Z-2311-2016: AmediCheck Instant Test Cup, Part No. C-C0501A-3A Product Usage: The AmediCheck…
FDA device recall · Class III · Branan Medical Corporation
Key facts
| Recall number (Z-number) | Z-2311-2016 |
|---|---|
| Recall event | 74600 |
| Product | AmediCheck Instant Test Cup, Part No. C-C0501A-3A Product Usage: The AmediCheck Instant Test Cup is an in vitro diagnostic test for the rapid detection of the following drugs in human urine. Drug Analyte Cut off Device Code Marijuana THC 50 ng/mL THC Cocaine Benzoylecgonine 300 ng/mL COC Amphetamine… |
| Product code | DIO |
| Recalling firm | Branan Medical Corporation |
| Recall class | Class III |
| Status | Terminated |
| Termination date | Oct 4, 2016 |
| 510(k) numbers | K082898 |
| FEI number | 3003102590 |
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