Low risk — use of or exposure to this product is not likely to cause adverse health consequences.
EnLite Neonatal TREC Kit Recalled by PerkinElmer Health Sciences, Inc. Due to Unique Device Identifier (UDI) is missing from outer...
What You Should Do
Stop using this product immediately. Do not consume, use, or distribute it.
Return the product to the place of purchase for a full refund. If you have questions, contact PerkinElmer Health Sciences, Inc. directly.
Affected Products
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
Quantity: 73 kits
Why Was This Recalled?
Unique Device Identifier (UDI) is missing from outer kit box label.
Where Was This Sold?
This product was distributed to 2 states: AK, MA
About PerkinElmer Health Sciences, Inc.
PerkinElmer Health Sciences, Inc. has 10 total recalls tracked by RecallDetector.
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Data sourced from the FDA (Device). Last updated March 26, 2026. View original report