BEUDAMED
    FDA Enforcement Class II Terminated

    Coat-A-Count Direct Androstenedione, SMN 10381049, Catalog Number TKAN1. Siemens Healthcare Diagnostics

    Recall: Z-2058-2014 · Reported July 23, 2014

    Enforcement

    Recall Number
    Z-2058-2014
    Event ID
    68595
    Classification
    Class II
    Status
    Terminated
    Product Type
    Devices
    Firm
    Siemens Healthcare Diagnostics Inc.
    Voluntary / Mandated
    Voluntary: Firm initiated
    Initial Notification
    Letter
    Report Date
    July 23, 2014
    Initiation Date
    June 9, 2014
    Classification Date
    July 15, 2014
    Termination Date
    July 24, 2015
    Address
    5736 W 96th St, N/A, Los Angeles, CA, 90045-5544, United States

    Description

    Coat-A-Count Direct Androstenedione, SMN 10381049, Catalog Number TKAN1. Siemens Healthcare Diagnostics

    Reason

    The assay is demonstrating a higher frequency of results greater than 10 ng/mL compared to alternate platforms.

    Code Info

    Lot No. TKAN1 batch 587 TKAN1 batch 588 TKAN1 batch 589 TKAN1 batch 590 TKAN1 batch 591 TKAN1 batch 592 TKAN1 batch 593 TKAN1 batch 594 TKAN1 batch 595 TKAN1 batch 596 TKAN1 batch 597 TKAN1 batch 598 TKAN1 batch 599 TKAN1 batch 600

    Distribution

    Worldwide Distribution. US nationwide including CA, MI, NC, NE, NY, OH, PA, TX, and VA; Argentina, Austria, Belgium, Bolivia, Canada, Chile, Colombia, Finland, Germany, Great Britain, Greece, India, Ireland, Italy, Japan, Korea, Netherlands, Paraguay, Peru, South Africa, Spain, Sweden, Switzerland, and Uruguay

    Quantity

    1,164 units