BEUDAMED
    FDA Recall Open, Classified

    DELFIA hCG Kit, In Vitro Diagnostic for the determination of human gonadotropin (hCG) Product Code: A007-101 - Product Usage: Quantitative determination of human gonadotrophin (hCG) in serum.

    Recall: Z-1237-2019 · Initiated January 10, 2019

    Recall

    Recall Number
    Z-1237-2019
    Event Number
    82064
    Firm
    PerkinElmer Life and Analytical Sciences, Wallac, OY Mustionkatu 6
    FEI Number
    3002808498
    Product Code
    JHJ
    Status
    Open, Classified
    Root Cause
    Nonconforming Material/Component
    Initiated
    January 10, 2019
    Address
    P.O. Box 10, Turku Finland

    Description

    DELFIA hCG Kit, In Vitro Diagnostic for the determination of human gonadotropin (hCG) Product Code: A007-101 - Product Usage: Quantitative determination of human gonadotrophin (hCG) in serum.

    Reason

    hCG analyte concentrations may be decreased up to 15- 20% at the lower measuring range of hCG concentrations.

    Action

    Perkin Elmer initiated notification on January 10, 2018. The Recall Letter delivered to the end customer by email facilitated through the PerkinElmer Technical Support Group. PerkinElmer requires customers to: Inspect DELFIA / AutoDELFIA hCG kit inventory for the affected lots. Review your QC follow-up of the AutoDELFIA hCG assay for potential decrease in the control concentrations. If the control values are within your established acceptance range it is safe to report the results To avoid unnecessary repeat testing of samples, if the control values are out of the acceptance range discontinue use of the DELFIA / AutoDELFIA hCG kit lot and dispose the remaining kits of the lot. Complete the Response Form with the quantity of affected DELFIA / AutoDELFIA hCG kits you have disposed from your inventory

    Distribution

    Worldwide distribution - US Nationwide distribution. and countries of Austria, Bolivia, UK, Switzerland,Thailand, Finland.

    Quantity

    31 kits (10 in US, 21 in ROW)