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.
Recall
- Recall Number
- Z-2322-2015
- Event Number
- 71550
- Firm
- Acon Laboratories, Inc.
- FEI Number
- 3003516723
- Product Code
- DJZ
- Status
- Terminated
- Root Cause
- Labeling False and Misleading
- Initiated
- June 17, 2015
- Posted
- July 30, 2015
- Terminated
- December 8, 2015
- Address
- 10125 Mesa Rim Rd, San Diego, CA, 92121-2915
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.
Acon Laboratories, Inc. is recalling Mission Breath Alcohol Detector due to a labeling amendment.
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 858-857-8011.
U.S. Nationwide Distribution in the states of: NY, CA, FL, VA, LA, NJ, MN, PA, MI, OH, TX, VA, UT, AL, and GA
1,283 kits