FDA-Device2015-08-05Class III
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.
Acon Laboratories, Inc.
Hazard
Acon Laboratories, Inc. is recalling Mission Breath Alcohol Detector due to a labeling amendment.
Sold states
U.S. Nationwide Distribution in the states of: NY, CA, FL, VA, LA, NJ, MN, PA, MI, OH, TX, VA, UT, AL, and GA
Affected count
1,283 kits
Manufactured in
10125 Mesa Rim Rd, N/A, San Diego, CA, United States
Products
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.
Official notice
https://www.accessdata.fda.gov/scripts/ires/index.cfm?Product=Z-2322-2015Don't want to check this manually?
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