Recall Z-2322-2015— Acon Laboratories, Inc.
Class III · Terminated
Class III FDA medical device recall by Acon Laboratories, Inc., initiated 2015-06-17, terminated 2015-12-08. It names one FDA 510(k) clearance: K093143. 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.. Reason: Acon Laboratories, Inc. is recalling Mission Breath Alcohol Detector due to a labeling amendment..
- Recalling firm
- Acon Laboratories, Inc.
- Classification
- Class III
- Status
- Terminated
- Initiated
- 2015-06-17
- Terminated
- 2015-12-08
- Firm location
- San Diego, CA, United States
510(k) clearances named in this recall
1 on FDA's recordK-numbers as listed on FDA's Recall Enterprise System record for this event (openFDA device/recall k_numbers). The recall may also cover devices cleared under other submissions not named here.
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.
Reason for recall
Acon Laboratories, Inc. is recalling Mission Breath Alcohol Detector due to a labeling amendment.
Data sourced from openFDA. This site is unofficial and independent of the FDA.