Device recall
Z-1541-2018: Specimen Gate Screening Center, Part Number 5002-0500, All software versions…
FDA device recall · Class II · PerkinElmer Life and Analytical Sciences, Wallac, OY
Key facts
| Recall number (Z-number) | Z-1541-2018 |
|---|---|
| Recall event | 79421 |
| Product | Specimen Gate Screening Center, Part Number 5002-0500, All software versions from 1.0 to 1.8 (current software version) Specimen Gate Screening Center is used for data management of neonatal screening test results and demographics by qualified laboratory personnel in newborn screening programs. |
| Product code | JQP |
| Recalling firm | PerkinElmer Life and Analytical Sciences, Wallac, OY |
| Recall class | Class II |
| Status | Terminated |
| Termination date | Aug 12, 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