BEUDAMED
    FDA Recall Terminated

    Agendia MammaPrint, Catalog Numbers MP01, MP US version 03

    Recall: Z-1321-2010 · Initiated March 3, 2010

    Recall

    Recall Number
    Z-1321-2010
    Event Number
    54930
    Firm
    Agendia Inc
    FEI Number
    3007297853
    Product Code
    NYI
    Status
    Terminated
    Root Cause
    Other
    Initiated
    March 3, 2010
    Posted
    April 12, 2010
    Terminated
    June 18, 2010
    Address
    17742 Beach Blvd, Ste 250, Huntington Beach, CA, 92647-6835

    Description

    Agendia MammaPrint, Catalog Numbers MP01, MP US version 03

    Reason

    Over a period of about 6 months in about 15% of results provided Agendia has been "over reporting" the chance of metastasis risk being 29% risk of recurrence instead of 10% risk. This over reporting of risk did not cause direct injury to patients. However, if used by physicians as the sole basis for decision-making, affected patients may have received unnecessary therapy.

    Action

    Communication with physicians was initiated by the firm's Chief Medical Officer on March 3, 2010. The firm's representatives will meet with treating physicians in person while having the corrected results in hand to inform each in person of the action, to allow a decision of the best course of action. Physicians will be provided with background information on the issue at hand and corrected results. As follow up, the physician would receive a corrected report per patient by FedEx in order to register the reception of corrected information. Because each user received a personal visit, no other contact information was planned or provided by Agendia.

    Distribution

    Nationwide.

    Quantity

    107