BEUDAMED
    FDA Recall Terminated

    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

    Recall: Z-0897-2017 · Initiated December 5, 2016

    Recall

    Recall Number
    Z-0897-2017
    Event Number
    75862
    Firm
    PerkinElmer Health Sciences, Inc.
    FEI Number
    3006159931
    Product Code
    PJI
    Status
    Terminated
    Root Cause
    Employee error
    Initiated
    December 5, 2016
    Posted
    December 22, 2016
    Terminated
    February 6, 2017

    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

    Unique Device Identifier (UDI) is missing from outer kit box label.

    Action

    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 [email protected] as soon as possible, but not later than December 29, 2016.

    Distribution

    MA, AK

    Quantity

    73 kits