BEUDAMED
    FDA Recall Terminated

    Accu-Chek Advantage glucose test strips; part numbers 336, 556, 787 and 966.

    Recall: Z-0716-03 · Initiated February 12, 2003

    Recall

    Recall Number
    Z-0716-03
    Event Number
    25542
    Firm
    Roche Diagnostics Corp.
    FEI Number
    1823260
    Product Code
    LFR
    Status
    Terminated
    Root Cause
    Other
    Initiated
    February 12, 2003
    Posted
    April 9, 2003
    Terminated
    September 15, 2003
    Address
    9115 Hague Road, Indianapolis, IN, 46250-0457

    Description

    Accu-Chek Advantage glucose test strips; part numbers 336, 556, 787 and 966.

    Reason

    Crack in the bottom of the test strip vial will cause erroneously low or high blood glucose readings.

    Action

    Urgent Product Correction letters dated 2/12/03 were issued to pharmacists, specific health care providers, and the laboratory manager at customer accounts. Letter recipients were asked to advise their patients to inspect their vial for a crack prior to each use.

    Distribution

    United States, Argentina, Australia, Brazil, Canada, Chile, China, Colombia, Denmark, Finland, France, Germany, Guatemala, Honduras, Hong Kong, Indonesia, Japan, Malaysia, Mexico, New Zealand, Norway, Pakistan, Peru, Philippines, Portugal, Singapore, South Africa, South Korea, Spain, Taiwan, Thailand, United Kingdom and Vietnam.