Home / Recalls / Acon Laboratories, Inc. / Z-2322-2015

Z-2322-2015 Class III Terminated

Recalled by Acon Laboratories, Inc. — San Diego, CA

Recall Details

Product Type: Devices
Report Date: August 5, 2015
Initiation Date: June 17, 2015
Termination Date: December 8, 2015
Voluntary/Mandated: Voluntary: Firm initiated
Product Quantity: 1,283 kits

Product 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 for Recall

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

Distribution Pattern

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

Code Information

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