Home / Recalls / PerkinElmer Health Sciences, Inc. / Z-0897-2017

Z-0897-2017 Class III Terminated

Recalled by PerkinElmer Health Sciences, Inc. — N/A

Recall Details

Product Type: Devices
Report Date: December 28, 2016
Initiation Date: December 5, 2016
Termination Date: February 6, 2017
Voluntary/Mandated: Voluntary: Firm initiated
Product Quantity: 73 kits

Product Description

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.

Distribution Pattern

MA, AK

Code Information

Lot Number: 1065060401

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