BEUDAMED
    FDA Recall 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 · Initiated September 25, 2017

    Recall

    Recall Number
    Z-1220-2018
    Event Number
    79198
    Firm
    PerkinElmer Life and Analytical Sciences, Wallac, OY Mustionkatu 6
    FEI Number
    3002808498
    Product Code
    JNO
    Status
    Terminated
    Root Cause
    Process control
    Initiated
    September 25, 2017
    Terminated
    September 6, 2018
    Address
    P.O. Box 10, Turku 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.

    Action

    Actions to be taken: Inspect your inventory of AutoDELFIA Neonatal IRT kits for batch number 1065647901 and replace the Quality Control Certificate included in the kit packaging with the revised certificate attached to this letter. If you have already used the kit lot there is no need to retest the samples reported if the results of the controls included in the assay were within your established acceptance range. Complete and return the enclosed response form identifying the quantity of affected kits in your possession. Please inform others affected in your organization accordingly. To comply with regulatory requirements we require that you complete the enclosed Response Form and return it.

    Distribution

    Distributed to CT and TX.

    Quantity

    240