BEUDAMED
    FDA Recall Terminated

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

    Recall: Z-0119-2020 · Initiated October 30, 2018

    Recall

    Recall Number
    Z-0119-2020
    Event Number
    83701
    Firm
    Horiba Instruments Incorporated
    FEI Number
    2086725
    Product Code
    CHI
    Status
    Terminated
    Root Cause
    Device Design
    Initiated
    October 30, 2018
    Terminated
    June 16, 2020
    Address
    34 Bunsen, Irvine, CA, 92618-4210

    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).

    Action

    A "field Safety Notice" was mailed to all consignees on XX/XX/XXXX via XXXX. The field safety notice informed customer of the following: 1. If your lipase result is > 38 U/L (or the reference (normal) value of your laboratory) rerun lipase alone: - If result is still > 38 U/L(or the reference value of your laboratory), report the result as abnormal. - If result is < 38 U/L(or the reference value of your laboratory), report the result as a normal. 2. To avoid rerun, another option is to perform lipase test in batch mode (all lipase tests executed consecutively in a same run). 3. Those recommendations will be added on the reagent notice for lipase test. The last revisions of these documents are available on our Documentation web site. 4. Please share this information with your laboratory staff, and retain this notification as part of your Quality System documentation. 5. Please complete and return the enclosed response form within 10 days, in order for us to verify your understanding of this Field Information. 6. If you have any questions regarding this Product Corrective Action, please contact your local Horiba Medical representative or our Technical Service Department at 888-903-5001, option 3, option 2.

    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