BEUDAMED
    FDA Enforcement Class II Terminated

    Wash Kit (REF 10680) Lots 16279, 17045 and 17215 Medica corporation is marketing a wash solution Chemistry Wash1 , REF # 10680 for use with Medica s EasyRA clinical chemistry analyzer. The solution is used prior to a lipase (LIP) assay if an interferant assay (TRIG)is part of the work list. The major interferant for Lipase is the Triglycerides (TRIG) assay since one of the reagents contains lipase as an active ingredient.

    Recall: Z-1149-2018 · Reported March 28, 2018

    Enforcement

    Recall Number
    Z-1149-2018
    Event ID
    79264
    Classification
    Class II
    Status
    Terminated
    Product Type
    Devices
    Firm
    Medica Corporation
    Voluntary / Mandated
    Voluntary: Firm initiated
    Initial Notification
    Letter
    Report Date
    March 28, 2018
    Initiation Date
    November 21, 2017
    Classification Date
    March 21, 2018
    Termination Date
    August 20, 2020
    Address
    5 Oak Park Dr, N/A, Bedford, MA, 01730-1430, United States

    Description

    Wash Kit (REF 10680) Lots 16279, 17045 and 17215 Medica corporation is marketing a wash solution Chemistry Wash1 , REF # 10680 for use with Medica s EasyRA clinical chemistry analyzer. The solution is used prior to a lipase (LIP) assay if an interferant assay (TRIG)is part of the work list. The major interferant for Lipase is the Triglycerides (TRIG) assay since one of the reagents contains lipase as an active ingredient.

    Reason

    The firm has initiated a field recall of the Wash1 Kit REF 10680 due to reported inconsistent Lipase values when analyzing patient samples. The firm's internal investigation identified the underlying cause to be an ineffective wash solution resulting in an interference carryover from the triglyceride (TRIG) assay if they are on the same worklist.

    Code Info

    Lots 16279, 17045 and 17215

    Distribution

    Worldwide and US Distribution.

    Quantity

    392