BEUDAMED
    FDA Recall 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 · Initiated February 6, 2019

    Recall

    Recall Number
    Z-1294-2019
    Event Number
    82217
    Firm
    Medica Corporation
    FEI Number
    1220972
    Product Code
    CHI
    Status
    Terminated
    Root Cause
    Process design
    Initiated
    February 6, 2019
    Terminated
    October 2, 2020
    Address
    5 Oak Park Dr, Bedford, MA, 01730-1430

    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.

    Action

    Medica issued letters dated 2/8/19 via email Bulletin B1901 & B1902 to distributors and end-users on record. Letter describes problem, action to be taken: Immediately discontinue use of the Wash1 wedges (REF 10680) and discard any remaining kits/wedges. Complete the response form. Discuss possible concerns about Lipase results achieved using these lots of Wash wedges with your laboratory manager and/or clinician in order to decide on appropriate measures. Report any concerns to Medica for evaluation and review. Questions contact Medica Technical Support at (877) 777-5895 or via email at: [email protected].

    Distribution

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

    Quantity

    87 kits