BEUDAMED
    FDA Recall Open, Classified

    IMMULITE 2000 Systems HCG [200 Tests, material number 10381206, catalog number L2KCG] and [600 Tests, material number 10381194, catalog number L2KCG6]

    Recall: Z-1015-2022 · Initiated February 22, 2022

    Recall

    Recall Number
    Z-1015-2022
    Event Number
    89900
    Firm
    Siemens Healthcare Diagnostics, Inc.
    FEI Number
    2432235
    Product Code
    DHA
    Status
    Open, Classified
    Root Cause
    Under Investigation by firm
    Initiated
    February 22, 2022
    Address
    511 Benedict Ave, Tarrytown, NY, 10591-5005

    Description

    IMMULITE 2000 Systems HCG [200 Tests, material number 10381206, catalog number L2KCG] and [600 Tests, material number 10381194, catalog number L2KCG6]

    Reason

    Potential for falsely elevated hCG results due to sample carryover in serum and urine patient samples, as well as quality control samples and adjustors.

    Action

    Urgent Medical Device Correction was issued February 02, 2022 via Fed Ex. Notification provides instructions to customers to mitigate this sample carryover. Customers are requested to complete and return the Effectiveness Check questionnaire. Contact your local Siemens Healthineers technical support representative with any questions.

    Distribution

    Worldwide distribution - US Nationwide distribution in the states of AZ, CA, CO, FL, GA, HI, ID, IN, MN, NC, NH, NJ, NM, NV, NY, OH, OR, PA, SC, TX, VA, WI, WY and OUS: 81 countries.

    Quantity

    10,755 boxes (533 US, 10,222 OUS)