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PerkinElmer Health Sciences, Inc. recalls EnLite Neonatal TREC Kit;an in vitro diagnostic device intended for the semi-quantitative determination of TREC (T-cell
Recalled December 28, 2016 · FDA recall Z-0897-2017 · PerkinElmer Health Sciences
Hazard
Unique Device Identifier (UDI) is missing from outer kit box label. · FDA Class III
Units
73 kits
Sold at
MA, AK
Description
Unique Device Identifier (UDI) is missing from outer kit box label.
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
Manufacturer(s)
PerkinElmer Health Sciences, Inc.
Source: U.S. Food and Drug Administration. Official recall notice on fda.gov →