Device recall
Z-0315-2016: ProScreen 10 Drug Panel Cassette Test, Item No. CPSP-10PPX; ProScreen 10 Panel…
FDA device recall · Class II · Ameditech Inc
Key facts
| Recall number (Z-number) | Z-0315-2016 |
|---|---|
| Recall event | 72471 |
| Product | ProScreen 10 Drug Panel Cassette Test, Item No. CPSP-10PPX; ProScreen 10 Panel Cup, Item No. PSCup-10MMO-300, PSCup-10M, PSCupA-10MO, PSCUp-10AB; ProScreen 10 Panel Cup with Adulterants, Item No. PSCupA-10AM; ProScreen 10 Panel Dip Card, Item No. PSD-10MMO-300, PSD-10MOX, PSD-10M, PSD-10CMO3… |
| Product code | JXM |
| Recalling firm | Ameditech Inc |
| Recall class | Class II |
| Status | Terminated |
| Termination date | Nov 9, 2016 |
| 510(k) numbers | K052115 |
| FEI number | 3003789989 |
At a glance
- 1–9 Linked 510(k)s
- 10–99 Products in the same recall event
- 100–999 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