BEUDAMED
    FDA Recall Terminated

    Tosoh brand AIA-PACK CA 19-9 Test Cup Set used in TOSOH AIA Immunoassay Analyzers, A pack contains 10 trays of 20 test cups, Catalog #: 020271, For IN VITRO Diagnostic Use, The product is manufactured by TOSOH CORPORATION, TOKYO, JAPAN

    Recall: Z-0197-05 · Initiated September 23, 2004

    Recall

    Recall Number
    Z-0197-05
    Event Number
    30182
    Firm
    Tosoh Bioscience, Inc.
    FEI Number
    1000123732
    Product Code
    NIG
    Status
    Terminated
    Root Cause
    Other
    Initiated
    September 23, 2004
    Posted
    November 16, 2004
    Terminated
    December 10, 2004
    Address
    347 Oyster Point Blvd, Ste 201, South San Francisco, CA, 94080-1913

    Description

    Tosoh brand AIA-PACK CA 19-9 Test Cup Set used in TOSOH AIA Immunoassay Analyzers, A pack contains 10 trays of 20 test cups, Catalog #: 020271, For IN VITRO Diagnostic Use, The product is manufactured by TOSOH CORPORATION, TOKYO, JAPAN

    Reason

    On 10/30/04, the firm initiated the recall and its notification was via letters requesting return of affected devices.

    Action

    On 10/30/04, the firm initiated the recall and its notification was via letters requesting return of affected device.

    Distribution

    The firm distributed product to 10 consumers and 1 distributor, to locations in CA, CO, FL, MD, NY, OH, SC and TX. No federal government agency sales/distribution centers or foreign countries received the product. The last product distributed was on 6/15/2004.

    Quantity

    133 boxes