PerkinElmer Health Sciences, Inc. recalls EnLite Neonatal TREC Kit;an in vitro diagnostic device intended for the semi-quantitative determination of TREC (T-cell…
- Recall date
- December 5, 2016
- Source
- U.S. Food & Drug Administration (FDA) — enforcement report
- Recall number
- Z-0897-2017
- FDA classification
- Class III
- Brand / firm
- PerkinElmer Health Sciences, Inc.
- Sold / distributed
- MA, AK
Why it was recalled
Unique Device Identifier (UDI) is missing from outer kit box label.
Class III means the product violates regulations but is not likely to cause harm.
What was recalled
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
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