BEUDAMED
    FDA Enforcement Class II Terminated

    ADVIA Centaur Progesterone; Catalog Number: 10310305 10315522 10333111 Product Usage: The PROG method is an in vitro diagnostic test for the quantitative measurement of progesterone in human serum and plasma on the Dimension Vista¿System. Progesterone measurements are used in the diagnosis and treatment of disorders of the ovaries or placenta.

    Recall: Z-1418-2017 · Reported March 15, 2017

    Enforcement

    Recall Number
    Z-1418-2017
    Event ID
    76212
    Classification
    Class II
    Status
    Terminated
    Product Type
    Devices
    Firm
    Siemens Healthcare Diagnostics, Inc
    Voluntary / Mandated
    Voluntary: Firm initiated
    Initial Notification
    Letter
    Report Date
    March 15, 2017
    Initiation Date
    January 4, 2017
    Classification Date
    March 9, 2017
    Termination Date
    July 18, 2019
    Address
    333 Coney St, N/A, East Walpole, MA, 02032-1516, United States

    Description

    ADVIA Centaur Progesterone; Catalog Number: 10310305 10315522 10333111 Product Usage: The PROG method is an in vitro diagnostic test for the quantitative measurement of progesterone in human serum and plasma on the Dimension Vista¿System. Progesterone measurements are used in the diagnosis and treatment of disorders of the ovaries or placenta.

    Reason

    DHEA-S causes falsely elevated progesterone results.

    Code Info

    SMN: 10310305: 75422274 83380274 89389274 99473274 8713275 19796275 30565275 38674275 46515276 55704276 66971276 78934276 80930277; SMN: 10315522: 74355274 80476274 87497274 20274 7772275 14822275 25943275 35303275 43229276 46525276 55505276 67430276 80448276 81415277; SMN: 10333111: 84848274 89946274 14006275 33598275 49907276 66978276

    Distribution

    US Nationwide distribution including Puerto Rico

    Quantity

    76,107