BEUDAMED
    FDA Recall Terminated

    Atellica CH Ethyl Alcohol, Test Code ETOH, Siemens Material Number (SMN) 11097501, UDI 00630414596112. The product is an ethyl alcohol assay, IVD use.

    Recall: Z-1599-2020 · Initiated February 14, 2020

    Recall

    Recall Number
    Z-1599-2020
    Event Number
    85020
    Firm
    Siemens Healthcare Diagnostics, Inc.
    FEI Number
    2432235
    Product Code
    DIC
    Status
    Terminated
    Root Cause
    Under Investigation by firm
    Initiated
    February 14, 2020
    Posted
    February 27, 2020
    Terminated
    February 22, 2024
    Address
    511 Benedict Ave, Tarrytown, NY, 10591-5005

    Description

    Atellica CH Ethyl Alcohol, Test Code ETOH, Siemens Material Number (SMN) 11097501, UDI 00630414596112. The product is an ethyl alcohol assay, IVD use.

    Reason

    The assay may exhibit a positive bias in QC and patient results within the 10-day pack calibration interval.

    Action

    On February 11, 2020, the firm issued an Urgent Medical Device Correction to all US customers. Customers who experience the issue were instructed to perform a pack calibration every 2 days or more frequently based on the laboratory's Quality Control performance. The firm is working to address the issue in a future software version. Customers are requested to complete and return the effectiveness check questionnaire. If you have any questions, contact your local Siemens Healthineers technical support representative.

    Distribution

    Domestic distribution nationwide. Foreign distribution to Australia, Austria, Bahamas, Belgium, Canada, Curacao, Chile, Colombia, Czech Republic, Denmark, Finland, France, Germany, India, Israel, Italy, Japan, Kenya, Latvia, Mexico, Netherlands, Norway, Poland, Portugal, Slovakia, South Korea, Spain, Sweden, Switzerland, Taiwan, Turkey, U.A.E., Uruguay, United Kingdom, and Vietnam.

    Quantity

    1124