BEUDAMED
    FDA Recall 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 · Initiated November 21, 2017

    Recall

    Recall Number
    Z-1149-2018
    Event Number
    79264
    Firm
    Medica Corporation
    FEI Number
    1220972
    Product Code
    CHI
    Status
    Terminated
    Root Cause
    Under Investigation by firm
    Initiated
    November 21, 2017
    Terminated
    August 20, 2020
    Address
    5 Oak Park Dr, Bedford, MA, 01730-1430

    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.

    Action

    Firm emailed all consignees and instructed them to remove/discard affected wedges (bottles) and contact Medica for immediate replacement 1 Immediately discontinue use of the Wash1 wedges (REF 10680) (Lot# listed above) and discard any remaining kits/wedges. 2. Please 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. 3.Submit claims for replacement of affected product to your authorized Medica EasyRA dealer. For further questions, please call (781) 541-7560.

    Distribution

    Worldwide and US Distribution.

    Quantity

    392