BEUDAMED
    FDA Enforcement Class III Terminated

    Mission -Breath Alcohol Detector -15 tests - 0.08% BAC - Blow bags included Product Usage: The Breath Alcohol Detector is for the semi-quantitative rapid detection of the presence of alcohol in the exhaled breath. The Breath Alcohol Detector indicated relative Blood Alcohol Concentration (BAC) at 0.02%, 0.04%, 0.05%, 0.06%, 0.08%, or 0.10% cut-off levels.

    Recall: Z-2322-2015 · Reported August 5, 2015

    Enforcement

    Recall Number
    Z-2322-2015
    Event ID
    71550
    Classification
    Class III
    Status
    Terminated
    Product Type
    Devices
    Firm
    Acon Laboratories, Inc.
    Voluntary / Mandated
    Voluntary: Firm initiated
    Initial Notification
    Letter
    Report Date
    August 5, 2015
    Initiation Date
    June 17, 2015
    Classification Date
    July 30, 2015
    Termination Date
    December 8, 2015
    Address
    10125 Mesa Rim Rd, N/A, San Diego, CA, 92121-2915, United States

    Description

    Mission -Breath Alcohol Detector -15 tests - 0.08% BAC - Blow bags included Product Usage: The Breath Alcohol Detector is for the semi-quantitative rapid detection of the presence of alcohol in the exhaled breath. The Breath Alcohol Detector indicated relative Blood Alcohol Concentration (BAC) at 0.02%, 0.04%, 0.05%, 0.06%, 0.08%, or 0.10% cut-off levels.

    Reason

    Acon Laboratories, Inc. is recalling Mission Breath Alcohol Detector due to a labeling amendment.

    Code Info

    -BAD4040003 (48 kits) -BAD4080006 (59 kits) -BAD5010010/BAD5040013/BAD5010011 (total of 1,176 kits)

    Distribution

    U.S. Nationwide Distribution in the states of: NY, CA, FL, VA, LA, NJ, MN, PA, MI, OH, TX, VA, UT, AL, and GA

    Quantity

    1,283 kits