FDA Device recall Z-0897-2017
EnLite Neonatal TREC Kit;an in vitro diagnostic device intended for the semi-quantitative determination of TREC (T-cell receptor excision c…
- FDA Device
- Class III
- terminated
- Published 2016-12-28
On 2016-12-28 the FDA classified a Class III recall of EnLite Neonatal TREC Kit;an in vitro diagnostic device intended for the semi-quantitative determination of TREC (T-cell receptor excision c… by Perkinelmer Health Sciences, citing unique Device Identifier (UDI) is missing from outer kit box label.
Read the official FDA Device notice
| Agency | FDA Device |
|---|---|
| Recall number | Z-0897-2017 |
| Classification | Class III |
| Status | terminated |
| Initiated | 2016-12-05 |
| Published | 2016-12-28 |
| Last updated | 2026-09-13 11:54 UTC |
| Company | Perkinelmer Health Sciences |
| Distribution | AK, MA |
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
Unique Device Identifier (UDI) is missing from outer kit box label.
Identifiers
| code_info | Lot Number: 1065060401 |
|---|
Status history
No status changes recorded since RecallRadar first saw this recall on 2026-09-13 11:54 UTC. Current status: terminated.
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Source
Official record: https://api.fda.gov/device/enforcement.json?search=recall_number:%22Z-0897-2017%22
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