BEUDAMED
    FDA Enforcement Class III Terminated

    AutoDELFIA Neonatal immunoreactive trypsin(ogen) (IRT) kit, intended for the quantitative determination of human immunoreactive trypsin(ogen) (IRT) in blood specimens. (UDI: (01)06438147298716(17)190430(10)656479); Product Number: B005-212

    Recall: Z-1220-2018 · Reported September 12, 2018

    Enforcement

    Recall Number
    Z-1220-2018
    Event ID
    79198
    Classification
    Class III
    Status
    Terminated
    Product Type
    Devices
    Firm
    PerkinElmer Life and Analytical Sciences, Wallac, OY
    Voluntary / Mandated
    Voluntary: Firm initiated
    Initial Notification
    E-Mail
    Report Date
    September 12, 2018
    Initiation Date
    September 25, 2017
    Classification Date
    August 31, 2018
    Termination Date
    September 6, 2018
    Address
    Mustionkatu 6, P.O. Box 10, Turku, N/A, N/A, Finland

    Description

    AutoDELFIA Neonatal immunoreactive trypsin(ogen) (IRT) kit, intended for the quantitative determination of human immunoreactive trypsin(ogen) (IRT) in blood specimens. (UDI: (01)06438147298716(17)190430(10)656479); Product Number: B005-212

    Reason

    The Quality Control Certificate for certain AutoDELFIA Neonatal IRT Kits is missing information required to assess the acceptability of measured control values which may result in a delay in reporting IRT results.

    Code Info

    Lot Number: 656479, Batch Number: 1065647901, Expiration date: 2019-4-30

    Distribution

    Distributed to CT and TX.

    Quantity

    240