BEUDAMED
    FDA Recall Terminated

    AIA-PACK TPOAb CONTROL SET

    Recall: Z-2168-2017 · Initiated February 8, 2017

    Recall

    Recall Number
    Z-2168-2017
    Event Number
    76659
    Firm
    Tosoh Bioscience, Inc.
    FEI Number
    1000123732
    Product Code
    JZO
    Status
    Terminated
    Root Cause
    Labeling mix-ups
    Initiated
    February 8, 2017
    Posted
    May 15, 2017
    Terminated
    February 8, 2019
    Address
    6000 Shoreline Ct, Ste 101, South San Francisco, CA, 94080-7606

    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.

    Action

    On 3/3/2017 the firm sent recall notificaion letters to their customers.

    Distribution

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

    Quantity

    15 boxes