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

Recalled August 5, 2015 · FDA recall Z-2322-2015 · Acon Laboratories

Hazard

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

Units

1,283 kits

Sold at

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

Description

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

Product

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.

Manufacturer(s)

Acon Laboratories, Inc.

Source: U.S. Food and Drug Administration. Official recall notice on fda.gov →