Drug recall
EnLite Neonatal TREC Kit;an in vitro diagnostic device intended for the semi-quantitative determination of…
FDA recall event 75862 · Class III · PerkinElmer Health Sciences, Inc.
Key facts
| Event ID | 75862 |
|---|---|
| Recall numbers | Z-0897-2017 |
| Recalling firm | PerkinElmer Health Sciences, Inc. |
| Product type | Devices |
| Products | 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… |
| Classification | Class III |
| Status | Terminated |
| Voluntary or mandated | Firm Initiated |
| Reason for recall | Unique Device Identifier (UDI) is missing from outer kit box label. |
| Initiation date | Dec 5, 2016 |
| Report date | Dec 28, 2016 |
| Termination date | Feb 6, 2017 |
| FEI number | 3006159931 |
At a glance
- 1–9 Products in this recall
- 1–9 FDA inspections of this firm (FEI)
Counts are shown as ranges. Exact figures, trends and every underlying record are available in Orca1.
About FDA drug and product recalls
FDA enforcement reports list recalls of drugs, biologics, foods and other FDA-regulated products, classified by the potential health hazard.
Source: U.S. Food and Drug Administration (FDA), Enforcement Reports · Source date: