Device 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
Z-0897-2017
Product summary
- Event
- Event 75862
- Status
- Terminated
- Classification
- Class III
- Quantity
- 73 kits
- Official record key
device-enforcement:Z-0897-2017
Official wording
Reason: Unique Device Identifier (UDI) is missing from outer kit box label.
Code information: Lot Number: 1065060401
Distribution pattern: MA, AK
Derived failure modes
-
Unknown
Unique Device Identifier (UDI) is missing from outer kit box label.