Acon Laboratories, Inc.: Medical Device Recall in 2015 - (Recall #: Z-2322-2015)

Updated on March 25, 2026.

See the recall detail below. You can also see other recalls from the same firm in 2015.

Data Source: FDA.

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.

Product Classification:

Class III

Date Initiated: June 17, 2015

Date Posted: August 5, 2015

Recall Number: Z-2322-2015

Event ID: 71550

Reason for Recall:

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

Status: Terminated

Product Quantity: 1,283 kits

Code Information:

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

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

Voluntary or Mandated:

Voluntary: Firm initiated