BEUDAMED
    FDA Recall Terminated

    Cholestech GDX A1C Test Cartridge. The Cholestech GDX A1C Test is an in-vitro diagnostic test that measures hemoglobin A1c (HbA1c).

    Recall: Z-2460-2008 · Initiated August 3, 2006

    Recall

    Recall Number
    Z-2460-2008
    Event Number
    49359
    Firm
    Cholestech Corp
    FEI Number
    1000123985
    Product Code
    LCP
    Status
    Terminated
    Root Cause
    Nonconforming Material/Component
    Initiated
    August 3, 2006
    Posted
    September 23, 2008
    Terminated
    October 7, 2009
    Address
    3347 Investment Blvd, Hayward, CA, 94545-3808

    Description

    Cholestech GDX A1C Test Cartridge. The Cholestech GDX A1C Test is an in-vitro diagnostic test that measures hemoglobin A1c (HbA1c).

    Reason

    Cholestech Corp. was notified by the foreign manufacturer of the A1C test cartridge that stability data indicated that the product would not meet performance claims through the end of its shelf life.

    Action

    A customer notification letter was sent to Cholestech consignees who had received product from this lot. The letter dated 8/3/2006 instructed customers to discontinue use of the lot of product, destroy product according to in-house standard procedures and contact Cholestech Technical Services for replacement. It also instructed to provide a copy of the letter to other users if the lot of product was further distributed. A response form was included with instructions to complete and return. Contact Cholestech Corp at 1-510-781-3505 for assistance.

    Distribution

    U.S. state of Colorado. OUS: India, Slovenia, Germany, Tunisia, Taiwan, Canada, Philippines, South Africa and Mexico

    Quantity

    9,324 Cartridges