FDA Medical Device · Z-0897-2017

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

Class III · Terminated

Unique Device Identifier (UDI) is missing from outer kit box label.

Affected lots / codes — check yours against thisLot Number: 1065060401

Recalling firm: PerkinElmer Health Sciences, Inc.
Classification: Class III (unlikely to cause harm)
Status: Terminated
Quantity: 73 kits
Distribution: MA, AK
Recall initiated: December 5, 2016
Classified: December 22, 2016
Terminated: February 6, 2017
Initiation: Voluntary: Firm initiated

Official source. This record is published by the U.S. FDA through the openFDA enforcement database. View the unmodified government record:
https://api.fda.gov/device/enforcement.json?search=recall_number%3A%22Z-0897-2017%22

Important. Recalls target specific lots and codes — compare the affected lots above against your own product. This page reproduces public FDA data for readability; EveryRecall is independent and not affiliated with the FDA.

Check this brand across all 8 databases →