Recall Z-2322-2015 ยท DJZ Devices, Breath Trapping, Alcohol
Acon Laboratories, Inc.
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.
| Date | Jul 30, 2015 (initiated Jun 17, 2015) |
| Status | Terminated |
| Reason | Acon Laboratories, Inc. is recalling Mission Breath Alcohol Detector due to a labeling amendment. |
| Root cause | Labeling False and Misleading |
| Action | On 06/17/15 the firm sent out customer notification letters to their distributors. The letter identified the affected product, problem and actions to be taken. In the letter the firm requests that Mission Breath Alcohol Detectors be quarantined. The firm asks that distributor complete the "fax back" form to allow for the return of unexpired product for a replacement. Once the form is received the firm is going to issue a return authorization number as well as provide a return label. The contact noted in the letter is Qiyi Xie MD, MPH, Sr. Officer Regulatory and Clinical Affairs at 858-857 |
| Quantity | 1,283 kits |
| 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 |
| FDA record | Open on fda.gov |
510(k) clearances named in this recall
| K093143 | MISSION BREATH ALCOHOL DETECTOR ACON Laboratories, Inc., Jan 28, 2010 |