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U.S. Department of Health and Human Services

Class 3 Device Recall ACON Mission Breath Alcohol Detector

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  Class 3 Device Recall ACON Mission Breath Alcohol Detector see related information
Date Initiated by Firm June 17, 2015
Date Posted July 30, 2015
Recall Status1 Terminated 3 on December 08, 2015
Recall Number Z-2322-2015
Recall Event ID 71550
510(K)Number K093143  
Product Classification Devices, breath trapping, alcohol - Product Code DJZ
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.
Code Information -BAD4040003 (48 kits) -BAD4080006 (59 kits) -BAD5010010/BAD5040013/BAD5010011 (total of 1,176 kits)  
Recalling Firm/
Manufacturer		 Acon Laboratories, Inc.
10125 Mesa Rim Rd
San Diego CA 92121-2915
For Additional Information Contact
858-875-8000
Manufacturer Reason
for Recall		 Acon Laboratories, Inc. is recalling Mission Breath Alcohol Detector due to a labeling amendment.
FDA Determined
Cause 2		 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 858-857-8011.
Quantity in Commerce 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
Total Product Life Cycle TPLC Device Report
1 A record in this database is created when a firm initiates a correction or removal action. The record is updated if the FDA identifies a violation and classifies the action as a recall, and it is updated for a final time when the recall is terminated. Learn more about medical device recalls.
2 Per FDA policy, recall cause determinations are subject to modification up to the point of termination of the recall.
3 For details about termination of a recall see Code of Federal Regulations (CFR) Title 21 §7.55.
510(K) Database 510(K)s with Product Code = DJZ and Original Applicant = ACON LABORATORIES, INC.
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