BEUDAMED
    FDA Recall Terminated

    Accu-Chek Inform blood glucose test strips; International Reference nos. 04535057001, 04647696001 and 04535120001.

    Recall: Z-1384-06 · Initiated June 27, 2006

    Recall

    Recall Number
    Z-1384-06
    Event Number
    35729
    Firm
    Roche Diagnostics Corp.
    FEI Number
    1823260
    Product Code
    LFR
    Status
    Terminated
    Root Cause
    Other
    Initiated
    June 27, 2006
    Posted
    August 11, 2006
    Terminated
    May 4, 2007
    Address
    9115 Hague Rd, Indianapolis, IN, 46256-1025

    Description

    Accu-Chek Inform blood glucose test strips; International Reference nos. 04535057001, 04647696001 and 04535120001.

    Reason

    The drying agent beads, located in the cap, may become loose and fall into the vial causing the test strips to potentially give incorrect blood glucose test results

    Action

    U.S. consignees, point of care coordinators or laboratory managers, long term care professionals, health care professionals, pharmacists, and mail order distributors were notified via letter dated 6/28/06 to cease using the strips and to contact the firm for replacement if they see loose beads in their vial. International accounts were also notified.

    Distribution

    Worldwide Distribution-USA and countries of Argentina, Australia, Brazil, Canada, Chile, China, Colombia, Ecuador, England, France, Germany, Hong Kong, India, Indonesia, Japan, Malaysia, Mexico, New Zealand, Pakistan, Paraguay, Peru, Philippines, Singapore, South Africa, South Korea, Spain, Sweden, Taiwan, Thailand and Uruguay.

    Quantity

    21,000,000 consumer vials and 10,000,000 hospital vials to U.S. plus 35,000,000 vials international-(Totals for Recalls Z-1377-1384-06)