BEUDAMED
    FDA Enforcement Class II Ongoing

    AutoDELFIA¿ hCG Kit, In Vitro Diagnostic for the determination of human gonadotropin (hCG) Product Code: B007-101 - Product Usage: Quantitative determination of human gonadotrophin (hCG).

    Recall: Z-1238-2019 · Reported May 8, 2019

    Enforcement

    Recall Number
    Z-1238-2019
    Event ID
    82064
    Classification
    Class II
    Status
    Ongoing
    Product Type
    Devices
    Firm
    PerkinElmer Life and Analytical Sciences, Wallac, OY
    Voluntary / Mandated
    Voluntary: Firm initiated
    Initial Notification
    Letter
    Report Date
    May 8, 2019
    Initiation Date
    January 10, 2019
    Classification Date
    April 26, 2019
    Address
    Mustionkatu 6, P.O. Box 10, Turku, N/A, N/A, Finland

    Description

    AutoDELFIA¿ hCG Kit, In Vitro Diagnostic for the determination of human gonadotropin (hCG) Product Code: B007-101 - Product Usage: Quantitative determination of human gonadotrophin (hCG).

    Reason

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

    Code Info

    Kit Lot Numbers: 664670, 666553 Pack Lot Numbers: 1066467001, 1066467002, 1066655301 UDI: (01)06438147009336(17)190430(10)664670 (01)06438147009336(17)190430(10)666553

    Distribution

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

    Quantity

    79 kits (none in US, all in ROW)