Z-2322-2015Class III

Mission -Breath Alcohol Detector -15 tests - 0.08% BAC - Blow bags included

Name: Z-2322-2015 Mission -Breath Alcohol Detector -15 tests - 0.08% BAC - Blow bags included
Creator: Acon Laboratories, Inc.
Published: 2015-06-17
License: https://open.fda.gov/license/

Acon Laboratories, Inc. / initiated 2015-06-17 / Terminated / root cause: labeling and UDI

FDA source

Acon Laboratories, Inc. began a recall of Mission -Breath Alcohol Detector -15 tests - 0.08% BAC - Blow bags included Product Usage: The Breath Alcohol Detector is for the semi-quantitative rapid... on 2015-06-17. FDA classified it as Class III and gives the reason as "Acon Laboratories, Inc. is recalling Mission Breath Alcohol Detector due to a labeling amendment". As of 2026-09-10, the recall status on record is Terminated, and MDM tags the root cause as labeling and UDI.

Recall record

Recall number: Z-2322-2015
Classification: Class III
Status: Terminated
Initiated: 2015-06-17
Posted: 2015-07-30
Terminated: 2015-12-08
Recalling firm: Acon Laboratories, Inc.
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.
Product code: DJZ Devices, Breath Trapping, Alcohol
Reason for recall: Acon Laboratories, Inc. is recalling Mission Breath Alcohol Detector due to a labeling amendment.
Root cause tag: labeling and UDI
FDA 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 858-857-8011.
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
Product codes and lots: -BAD4040003 (48 kits) -BAD4080006 (59 kits) -BAD5010010/BAD5040013/BAD5010011 (total of 1,176 kits)

Enforcement reports

One row per recalled product line

FDA enforcement reports joined to recall event Z-2322-2015
Recall number	Class	Status	Voluntary or mandated	Report date	Classified
Z-2322-2015	Class III	Terminated	Voluntary: Firm initiated	2015-08-05	2015-07-30

Product code DJZ

K093143Class IMission Breath Alcohol DetectorACON Laboratories, Inc. / cleared 2010-01-28

MDM coverage of this record lists here, newest first.

About this record

Sourced from the FDA device recall database and the FDA enforcement reports, both ingested from openFDA. The recall record supplies the product, the reason and the product code; the enforcement report supplies the classification. The two datasets are exported by FDA on different days, and the date above is the older of the two, so nothing on this page is newer than it says.

MDM adds the root cause tag, derived from FDA’s own root cause text, and the cross-links to the product code, the clearances named on the record and MDM coverage. Where a recall has not been joined to an enforcement report, no classification is shown.

Data as of 2026-09-30, the FDA export date for this dataset. Page last changed 2026-09-05. View this recall on fda.gov (opens on fda.gov)