PerkinElmer Recalls EnLite Neonatal TREC Kits for Missing UDI Labels
PerkinElmer is recalling 73 EnLite Neonatal TREC Kits because the Unique Device Identifier (UDI) is missing from the outer box labels.
What this means for you
Cosmetic or documentation issue. No expected health impact, but the manufacturer is correcting the affected products.
Our severity reasoning: The recall is classified as FDA Class III, which by definition is unlikely to cause adverse health consequences. The issue is a missing label (documentation/packaging problem), fitting the 'Low' severity criteria for cosmetic or documentation issues.
Plain-English summary
PerkinElmer Health Sciences, Inc. is recalling 73 units of the EnLite Neonatal TREC Kit, product number 3401-001U, lot number 1065060401. The recall was initiated because the Unique Device Identifier (UDI) is missing from the outer kit box label. The EnLite Neonatal TREC Kit is an in vitro diagnostic device intended for the semi-quantitative determination of TREC DNA in blood specimens dried on filter paper, used as an aid in screening newborns for severe combined immunodeficiency disorder (SCID).
The affected kits were distributed to facilities in Massachusetts (MA) and Alaska (AK). This recall is classified as Class III by the U.S. Food and Drug Administration, indicating that the use of or exposure to the product is not likely to cause adverse health consequences.
Healthcare facilities and consumers who have this specific lot of the EnLite Neonatal TREC Kit should stop using the product and contact PerkinElmer Health Sciences, Inc. for instructions on return or replacement. The missing UDI label is a documentation and traceability issue rather than a defect in the diagnostic test itself.
The recalled product
- 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
- Manufacturer
- PerkinElmer Health Sciences, Inc.
- Hazard
- Affected units
- 73
Is your product affected?
Check your packaging against the codes below. If any of them match, the product is part of this recall.
Lot numbers (1)
- Lot Number: 1065060401
Distribution
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