EnLite Neonatal TREC Kit — Class III medical device recall Z-0897-2017
Terminated recall by PerkinElmer Health Sciences, Inc., reported 2016-12-28, distributed in AK, MA. Unique Device Identifier (UDI) is missing from outer kit box label.
| Recall number | Z-0897-2017 |
|---|---|
| Product type | Medical device |
| Classification | Class III |
| Status | Terminated |
| Voluntary or mandated | Voluntary |
| Recalling firm | PerkinElmer Health Sciences, Inc., N/A |
| Recall initiated | 2016-12-05 |
| Classified | 2016-12-22 |
| Reported by FDA | 2016-12-28 |
| Terminated | 2017-02-06 |
| Distributed | AK, MA |
| Quantity | 73 kits |
| Reason classes | labeling |
| Lot numbers | 1065060401 |
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 newborns for severe combined immunodeficiency disorder (SCID). Product Number: 3401-001U
Reason for recall
Unique Device Identifier (UDI) is missing from outer kit box label.
Machine access
This record, with every extracted code, the verbatim FDA record and provenance, is available from the recall API: GET https://api.data.aroqon.com/v1/recalls/Z-0897-2017. Look up any UPC, UDI, NDC or lot with /v1/recalls/lookup?code=…. API docs · free and paid keys.
Source: U.S. Food and Drug Administration enforcement report via openFDA (CC0). Structured by Data Foundry (recall-structuring@2); last changed 2026-09-26. Not affiliated with or endorsed by FDA. Not medical or legal advice.