Device Recall ACON Mission Breath Alcohol Detector

  • Model / Serial
    -BAD4040003 (48 kits) -BAD4080006 (59 kits) -BAD5010010/BAD5040013/BAD5010011 (total of 1,176 kits)
  • Product Classification
  • Device Class
  • Implanted device?
  • Distribution
    U.S. Nationwide Distribution in the states of: NY, CA, FL, VA, LA, NJ, MN, PA, MI, OH, TX, VA, UT, AL, and GA
  • 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.
  • Manufacturer
  • 1 Event


  • Manufacturer Address
    Acon Laboratories, Inc., 10125 Mesa Rim Rd, San Diego CA 92121-2915
  • Manufacturer Parent Company (2017)
  • Manufacturer comment
    “We are in constant communication with regulatory agencies and competent authorities worldwide which allows us to implement global recalls or in-country communication quickly and effectively,” Abbott, which now owns St. Jude Medical told ICIJ in a statement. In addition to sending global notices to physicians worldwide, we also make sure that product advisories are available online and classification of product recalls and product advisories are determined by global regulatory bodies which can impact the timing in any given country. MD companies follow varying regulations in different countries. In come countries software is not regulated so a recall in one country related to software would not be classified as a recall or field action in another. In addition, review cycles within the regulatory process can be different in each country which can impact communication and recall timing.
  • Source