BEUDAMED
    FDA Enforcement Class III Terminated

    Immunoradiometric assay. Device is an immunoradiometric assay designed for the quantitative measurement of thyroid stimulating hormone (thyrotropin, TSH) in serum. It is intended strictly for in vitro diagnostic. Used as an aid in the assessment of thyroid status.

    Recall: Z-0646-2013 · Reported January 16, 2013

    Enforcement

    Recall Number
    Z-0646-2013
    Event ID
    63852
    Classification
    Class III
    Status
    Terminated
    Product Type
    Devices
    Firm
    Siemens Healthcare Diagnostics
    Voluntary / Mandated
    Voluntary: Firm initiated
    Initial Notification
    E-Mail
    Report Date
    January 16, 2013
    Initiation Date
    November 28, 2012
    Classification Date
    January 7, 2013
    Termination Date
    October 28, 2013
    Address
    511 Benedict Ave, Tarrytown, NY, 10591-5005, United States

    Description

    Immunoradiometric assay. Device is an immunoradiometric assay designed for the quantitative measurement of thyroid stimulating hormone (thyrotropin, TSH) in serum. It is intended strictly for in vitro diagnostic. Used as an aid in the assessment of thyroid status.

    Reason

    The recall was initiated because Siemens Healthcare Diagnostics confirmed an under-recovery of dose values with some vials of Coat-A-Consta (CAC) IRMA TSH calibrators TSI4 (level B), TSI5 (level C), TSI6 (level D), TSI8 (level F), and TSI9 (level G) lot 035. The affected calibrator vials can be identified by a darker yellow color than normal. The TSI3 (level A), TSI7 (level E), and TSIX (level H)

    Code Info

    Lots 969 and 970

    Distribution

    Worldwide Distribution - USA including CA, GA, IL, IN, MI, MN, NY, and Puerto Rico. Internationally to Agentina, Bolivia, Brazil, Canada, Chile, Guatemala, South Korea, Philippines, Paraguay, Taiwan, and Uraguay,

    Quantity

    Lot 969=33 units (29 units foreign) Lot 970=7 units (42 units foreign)