BEUDAMED
    FDA Enforcement Class II Terminated

    Medica Wash1-Wash solution used prior to Lipase assay on the EasyRA clinical chemistry analyzer REF 10680 - Product Usage: For use in washing the probe of the Medica EasyRA Chemistry Analyzer. The wash solution in the wedge is used to prevent interference between certain tests.

    Recall: Z-1294-2019 · Reported May 15, 2019

    Enforcement

    Recall Number
    Z-1294-2019
    Event ID
    82217
    Classification
    Class II
    Status
    Terminated
    Product Type
    Devices
    Firm
    Medica Corporation
    Voluntary / Mandated
    Voluntary: Firm initiated
    Initial Notification
    Telephone
    Report Date
    May 15, 2019
    Initiation Date
    February 6, 2019
    Classification Date
    May 7, 2019
    Termination Date
    October 2, 2020
    Address
    5 Oak Park Dr, N/A, Bedford, MA, 01730-1430, United States

    Description

    Medica Wash1-Wash solution used prior to Lipase assay on the EasyRA clinical chemistry analyzer REF 10680 - Product Usage: For use in washing the probe of the Medica EasyRA Chemistry Analyzer. The wash solution in the wedge is used to prevent interference between certain tests.

    Reason

    Wash1 solution is ineffective in cleaning dispensing probe of TRIG and LDL reagents that interfere with the Lipase (LIP) assay on the EasyRA clinical chemistry analyzer.

    Code Info

    Lot #s 18066, 18133, 18235, 18317

    Distribution

    Worldwide distribution - US Nationwide and countries of IRAQ, FRANCE, INDIA, GEORGIA, GEORGIA, FRANCE GUATEMALA, KENYA, IRAN, ESTONIA.

    Quantity

    87 kits