BEUDAMED
    FDA Enforcement Class III Terminated

    AIA-PACK TPOAb CONTROL SET

    Recall: Z-2168-2017 · Reported June 7, 2017

    Enforcement

    Recall Number
    Z-2168-2017
    Event ID
    76659
    Classification
    Class III
    Status
    Terminated
    Product Type
    Devices
    Firm
    Tosoh Bioscience, Inc.
    Voluntary / Mandated
    Voluntary: Firm initiated
    Initial Notification
    Letter
    Report Date
    June 7, 2017
    Initiation Date
    February 8, 2017
    Classification Date
    May 26, 2017
    Termination Date
    February 8, 2019
    Address
    6000 Shoreline Ct Ste 101, South San Francisco, CA, 94080-7606, United States

    Description

    AIA-PACK TPOAb CONTROL SET

    Reason

    The label contains two different methodologies. Quality Control values for non-FDA approved methodology (CL) are on the label in addition to the FDA approved methodology values (AIA). Two sets of instructions were included on the label.

    Code Info

    TPOAb: G644783 Expires June 2017 & G844784 Expires August 2017

    Distribution

    Product was shipped to the following states: AK, FL, GA, MA, NY, NY, OH, OK & TX.

    Quantity

    15 boxes