Recall Z-0897-2017— PerkinElmer Health Sciences, Inc.
Class III · Terminated
Class III FDA medical device recall by PerkinElmer Health Sciences, Inc., initiated 2016-12-05, terminated 2017-02-06. FDA's recall record names no specific 510(k) clearance for this event. 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. Reason: Unique Device Identifier (UDI) is missing from outer kit box label..
- Recalling firm
- PerkinElmer Health Sciences, Inc.
- Classification
- Class III
- Status
- Terminated
- Initiated
- 2016-12-05
- Terminated
- 2017-02-06
- Firm location
- N/A
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.
Data sourced from openFDA. This site is unofficial and independent of the FDA.