BEUDAMED
    FDA Enforcement Class III 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 · Reported December 28, 2016

    Enforcement

    Recall Number
    Z-0897-2017
    Event ID
    75862
    Classification
    Class III
    Status
    Terminated
    Product Type
    Devices
    Firm
    PerkinElmer Health Sciences, Inc.
    Voluntary / Mandated
    Voluntary: Firm initiated
    Initial Notification
    Letter
    Report Date
    December 28, 2016
    Initiation Date
    December 5, 2016
    Classification Date
    December 22, 2016
    Termination Date
    February 6, 2017
    Address
    N/A, N/A, N/A, N/A

    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.

    Code Info

    Lot Number: 1065060401

    Distribution

    MA, AK

    Quantity

    73 kits