BEUDAMED
    FDA Recall Terminated

    Accu-Chek Sensor Comfort blood glucose test strips; Reference numbers 03261956170, 03261964170, 03146154192, 03146146192, 03374700023, 03374718023, 11895133192, 11895141192, 03522091016, 03051161003, 03051170003, 03322033122, 03322041122 and 03587304122 (All sold outside of the United States).

    Recall: Z-0571-06 · Initiated February 10, 2006

    Recall

    Recall Number
    Z-0571-06
    Event Number
    34485
    Firm
    Roche Diagnostics Corp.
    FEI Number
    1823260
    Product Code
    LFR
    Status
    Terminated
    Root Cause
    Other
    Initiated
    February 10, 2006
    Posted
    February 28, 2006
    Terminated
    February 8, 2007
    Address
    9115 Hague Rd, Indianapolis, IN, 46256-1025

    Description

    Accu-Chek Sensor Comfort blood glucose test strips; Reference numbers 03261956170, 03261964170, 03146154192, 03146146192, 03374700023, 03374718023, 11895133192, 11895141192, 03522091016, 03051161003, 03051170003, 03322033122, 03322041122 and 03587304122 (All sold outside of the United States).

    Reason

    There may be a thin piece of plastic across the mouth of the vial, preventing the cap from sitting snugly onto the vial and, if present, this situation will cause erroneously low or high blood glucose readings.

    Action

    Notifications (letters) dated 2/10/06 were sent to healthcare professionals, retail pharmacies, hospitals and mail order firms asking them to provide their customers with information instructing the users to inspect their strip vials and to not use strips from defective vials. Mail order accounts were instructed to forward the recall notification to end users.

    Distribution

    Nationwide, Argentina, Australia, Brazil, Canada, Chile, China, Colombia, Ecuador, England, France, Germany, Hong Kong, India, Indonesia, Japan, Malaysia, Mexico, New Zealand, Pakistan, Panama, Peru, Philippines, Poland, Russia, Singapore, South Africa, South Korea, Spain, Sweden, Taiwan and Thailand.