BEUDAMED
    FDA Enforcement Class II Terminated

    ACCU-CHEK Compact Plus Test Strips For use with: ACCU-CHEK Compact Plus Meters; 17 count sample strip 51 count retail strip; 102 count retail strip; 51 count MedBen strip 51 count Mail Order strip; Sample Kit 16 per case. The ACCU-CHEK Compact Plus Test Strips are for use with the ACCU-CHEK Compact Plus Blood Glucose Meter to quantitatively measure glucose (sugar) in fresh capillary whole blood samples drawn from the fingertips or palm.

    Recall: Z-1616-2014 · Reported May 21, 2014

    Enforcement

    Recall Number
    Z-1616-2014
    Event ID
    67961
    Classification
    Class II
    Status
    Terminated
    Product Type
    Devices
    Firm
    Roche Diagnostics Operations, Inc.
    Voluntary / Mandated
    Voluntary: Firm initiated
    Initial Notification
    Two or more of the following: Email, Fax, Letter, Press Release, Telephone, Visit
    Report Date
    May 21, 2014
    Initiation Date
    April 14, 2014
    Classification Date
    May 13, 2014
    Termination Date
    September 18, 2014
    Address
    9115 Hague Rd, Indianapolis, IN, 46256-1025, United States

    Description

    ACCU-CHEK Compact Plus Test Strips For use with: ACCU-CHEK Compact Plus Meters; 17 count sample strip 51 count retail strip; 102 count retail strip; 51 count MedBen strip 51 count Mail Order strip; Sample Kit 16 per case. The ACCU-CHEK Compact Plus Test Strips are for use with the ACCU-CHEK Compact Plus Blood Glucose Meter to quantitatively measure glucose (sugar) in fresh capillary whole blood samples drawn from the fingertips or palm.

    Reason

    Roche Diabetes Care has become aware the ACCU-CHEK Compact Plus test strips may produce erroneously low blood glucose readings in patients undergoing Ceftriaxone therapy. The interference is not described in the product labeling.

    Code Info

    5599423160, 5599415160, 5919967160, 5919959160, 5919983160, 5907675001

    Distribution

    Nationwide Distribution.

    Quantity

    590,136 boxes