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.
FDA Recall Z-2322-2015 · Posted 2015-07-30
Advertisement
Recalling FirmAcon Laboratories, Inc.
Recall StatusTerminated
Product CodeDJZ
Date Initiated2015-06-17
Date Terminated2015-12-08
Product Quantity1,283 kits
Reason for Recall
Acon Laboratories, Inc. is recalling Mission Breath Alcohol Detector due to a labeling amendment.
Firm 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.
Root Cause
Labeling False and Misleading
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
Related FDA 510(k) Records
Devices referenced by this recall via K-numbers.
Official Source
View FDA Recall →Source: FDA Enforcement Report / Recall database. Always confirm against the official FDA record.
Advertisement