BEUDAMED
    FDA Recall Terminated

    The XN-Series modules (XN-10, XN-20) are quantitative multi-parameter automated hematology analyzers intended for in vitro diagnostic use in screening patient populations found in clinical laboratories.

    Recall: Z-1945-2016 · Initiated December 18, 2014

    Recall

    Recall Number
    Z-1945-2016
    Event Number
    70054
    FEI Number
    3010421384
    Product Code
    GKZ
    Status
    Terminated
    Root Cause
    Device Design
    Initiated
    December 18, 2014
    Posted
    June 10, 2016
    Terminated
    July 25, 2016
    Address
    Sysmex Corporation 1 5 1 Wakinohamakaigandoori CHUO-KU Kobe-shi Japan

    Description

    The XN-Series modules (XN-10, XN-20) are quantitative multi-parameter automated hematology analyzers intended for in vitro diagnostic use in screening patient populations found in clinical laboratories.

    Reason

    There is a potential for elevated hemoglobin (Hgb) and impedance platelet count (PLT-I) values.

    Action

    Sysmex Corporation sent a Product Notification Field Correction letter were to all affected customers of record. The letters included instructions for customers to: 1) Review results with an unexpected increase in Hgb, MCH, MCHC, and/or PLT-I. The increase may result in a low or normal value being artificially elevated to either a normal result or a result above the reference ranges, or a high value being artificially increased. There is negligble impact to the RBC when the issue occurs; 2) The relationship with an elevated Hgb would cause the indices (MCH and MCHC) values to appear to be abnormally elevated and may result in the results being flagged for verification or indicated to be outside of reference ranges; 3) Review any "Turbidity/Hgb Interf?" flag which will automatically trigger at an MCHC of 37.5 g/dL; 4) If Hgb is affected, the PLT-I may be also. Review any PLT-I result when an unexpected increase in MCH/MCHC or "Turbidity/Hgb Interf?" flag occurs; 5) Gross interference is likely to trigger a flag, however there is a potential any interference could increase the Hgb or the PLT-I count from a lower level to an "normal" level. Follow laboratory protocol for confirming unexpected results. Customers were further advised that they will be contacted by a Sysmex Field Representative within 180 days to schedule an appointment to replace the rinse cup on the analyzer(s) and that version 00-16 software will be installed to change the rinsing sequence for the aspiration probe. Customers with questions are requested to e-mail the Sysmex Technical Assistance Center. Urgent questions can be answered by calling the Technical Assistance Center at 888-879-7639 (24 hours a day / 7 days a week).

    Distribution

    Worldwide Distribution - US to AK, AL, AR, AZ, CA, CO, CT, DE, FL, GA, HI, IA, ID, IL, IN, KS, KY, LA, MA, MD, ME, MI, MN, MO, MS, MT, NC, ND, NE, NH, NJ, NM, NV, NY, OH, OK, OR, PA, RI, SC, SD, TN, TX, UT, VA, VT, WA, WI, WY + District of Columbia + Guam; Internationally to Australia, Bahrain, Bangladesh, Cambodia, Canada, China, Germany, Hong Kong, India, Indonesia, Malaysia, Maldives, Mongolia, Mynamar, Nepal, New Zealand, Pakistan, Philippines, Singapore, South Korea, Sri Lanka, Taiwan, Thailand, and Vietnam. THE CORRECTION IS LIMITED TO XN-10/XN-20 UNITS DISTRIBUTED BY SYSMEX AMERICA, INC., INSTALLED AT END-USER SITES IN US, PUERTO RICO, AND CANADA.

    Quantity

    1,137 units (US) 54 units (Canada) 9 inventory