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
This recall has been terminated (originally issued December 22, 2016).
- Recall Initiated
- December 5, 2016
- Posted
- December 22, 2016
- Terminated
- February 6, 2017
- Recall Number
- Z-0897-2017
- Quantity
- 73 kits
- Official Source
- View on FDA website ↗
Reason for Recall
Unique Device Identifier (UDI) is missing from outer kit box label.
Distribution
MA, AK
Lot / Code Info
Lot Number: 1065060401
Root Cause
Employee error
Action Taken
Customers were notified of the recall via email on December 5, 2016. Technical Support will ensure the customers receive the Recall Letter and understand the recommended actions. Customers were asked to retain this Medical Device Correction in your laboratory documentation until the affected lot inventory is either depleted or reaches expiration and to complete the enclosed response form and return it by fax to number 1-330-825-8520 (United States) /+358 2 2678 357 (outside United States) or as scanned by e-mail to TurkuQMresponse@perkinelmer.com as soon as possible, but not later than December 29, 2016.