Device recall
Z-0152-2012: ProScreen PSCup-5M Waived, Catalog Number: PSCup-5M Waived Product Usage: The…
FDA device recall · Class II · Ameditech Inc
Key facts
| Recall number (Z-number) | Z-0152-2012 |
|---|---|
| Recall event | 60100 |
| Product | ProScreen PSCup-5M Waived, Catalog Number: PSCup-5M Waived Product Usage: The ProScreen Drugs of Abuse Test Cup is a one-step immunoassay for the qualitative detection of multiple drugs in human urine (refer to PN: 42141-PS-W). The ProScreen Drugs of Abuse Test Cup is used to obtain a visual… |
| Product code | DKZ |
| Recalling firm | Ameditech Inc |
| Recall class | Class II |
| Status | Terminated |
| Termination date | Jan 18, 2012 |
| 510(k) numbers | K052115 |
| FEI number | 3003789989 |
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