Device recall
Z-0897-2017: EnLite Neonatal TREC Kit;an in vitro diagnostic device intended for the…
FDA device recall · Class III · PerkinElmer Health Sciences, Inc.
Key facts
| Recall number (Z-number) | Z-0897-2017 |
|---|---|
| Recall event | 75862 |
| Product | EnLite Neonatal TREC Kit;an in vitro diagnostic device intended for the semi-quantitative determination of TREC (T-cell receptor excision circle) DNA in blood specimens dried on filter paper. The test is for use on the VICTOR" EnLite instrument. The test is indicated for use as an aid in screening… |
| Product code | PJI |
| Recalling firm | PerkinElmer Health Sciences, Inc. |
| Recall class | Class III |
| Status | Terminated |
| Termination date | Feb 6, 2017 |
| FEI number | 3006159931 |
At a glance
- None Linked 510(k)s
- 1–9 Products in the same recall event
- 1–9 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