Z-0897-2017 Class III Terminated
FDA device recall Z-0897-2017 was initiated by PerkinElmer Health Sciences, Inc. on December 5, 2016 and is designated Class III. Reason for recall: Unique Device Identifier (UDI) is missing from outer kit box label. The recall status is terminated (terminated February 6, 2017). Affected quantity: 73 kits.
Recall Details
- Product Type
- Devices
- Report Date
- December 28, 2016
- Initiation Date
- December 5, 2016
- Termination Date
- February 6, 2017
- Voluntary/Mandated
- Voluntary: Firm initiated
- Product Quantity
- 73 kits
Product Description
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
Reason for Recall
Unique Device Identifier (UDI) is missing from outer kit box label.
Distribution Pattern
MA, AK
Code Information
Lot Number: 1065060401