Acon Laboratories, Inc. recalls Mission -Breath Alcohol Detector -15 tests - 0.08% BAC - Blow bags included Product Usage: The Breath Alcohol Detector…

Recall date

June 17, 2015

Source

U.S. Food & Drug Administration (FDA) — enforcement report

Recall number

Z-2322-2015

FDA classification

Class III

Brand / firm

Acon Laboratories, Inc.

Sold / distributed

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

Why it was recalled

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

Class III means the product violates regulations but is not likely to cause harm.

What was recalled

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.