Device recall
Z-0166-2016: Perkin Elmer Specimen Gate, Screening Center. Data management of neonatal…
FDA device recall · Class II · Perkin Elmer Life Sciences Inc
Key facts
| Recall number (Z-number) | Z-0166-2016 |
|---|---|
| Recall event | 72013 |
| Product | Perkin Elmer Specimen Gate, Screening Center. Data management of neonatal screening test results and demographics by qualified laboratory personnel in newborn screening programs. |
| Product code | JQP |
| Recalling firm | Perkin Elmer Life Sciences Inc |
| Recall class | Class II |
| Status | Terminated |
| Termination date | Jan 21, 2021 |
| FEI number | 3002808498 |
At a glance
- None Linked 510(k)s
- 1–9 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