BEUDAMED
    FDA Enforcement Class II Terminated

    Clinical Chemistry, ABX Pentra Lipase CP, ABX Pentra 400/Pentrac400, REF: A11A01631, Model/Part # 1220001631, UDI # 03610230004944

    Recall: Z-0119-2020 · Reported October 16, 2019

    Enforcement

    Recall Number
    Z-0119-2020
    Event ID
    83701
    Classification
    Class II
    Status
    Terminated
    Product Type
    Devices
    Firm
    Horiba Instruments Incorporated
    Voluntary / Mandated
    Voluntary: Firm initiated
    Initial Notification
    Letter
    Report Date
    October 16, 2019
    Initiation Date
    October 30, 2018
    Classification Date
    October 10, 2019
    Termination Date
    June 16, 2020
    Address
    34 Bunsen, N/A, Irvine, CA, 92618-4210, United States

    Description

    Clinical Chemistry, ABX Pentra Lipase CP, ABX Pentra 400/Pentrac400, REF: A11A01631, Model/Part # 1220001631, UDI # 03610230004944

    Reason

    Potential for chemical analyzer to report abnormal results due to an interference with triglycerides CP and Cholesterol CP. An over estimation of the lipase concentration could be observed and a patient result could be declared abnormal by the instrument due to these interferences instead of normal result < 38 U/L (or < reference value used in your laboratory).

    Code Info

    All Lots; All Software versions

    Distribution

    US: AL, AZ, CA, CO, CT, FL, GA, IA, ID, IL, KS, KY, LA, MA, MD, MI, MN, MO, MS, MT, NC, NE, NJ, NM, NV, NY, OH, OK, OR, PA, RI, SC, TN, TX, UT, VA, WA, WI, WV, WY

    Quantity

    1539 Chemistry Analyzers