Device 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.
Z-2322-2015
Product summary
- Event
- Event 71550
- Status
- Terminated
- Classification
- Class III
- Quantity
- 1,283 kits
- Official record key
device-enforcement:Z-2322-2015
Official wording
Reason: Acon Laboratories, Inc. is recalling Mission Breath Alcohol Detector due to a labeling amendment.
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
Derived failure modes
-
Unknown
Acon Laboratories, Inc. is recalling Mission Breath Alcohol Detector due to a labeling amendment.