Mission -Breath Alcohol Detector -15 tests — Class III medical device recall Z-2322-2015
Terminated recall by Acon Laboratories, Inc., reported 2015-08-05, distributed nationwide. Acon Laboratories, Inc. is recalling Mission Breath Alcohol Detector due to a labeling amendment.
| Recall number | Z-2322-2015 |
|---|---|
| Product type | Medical device |
| Classification | Class III |
| Status | Terminated |
| Voluntary or mandated | Voluntary |
| Recalling firm | Acon Laboratories, Inc., San Diego, CA, United States |
| Recall initiated | 2015-06-17 |
| Classified | 2015-07-30 |
| Reported by FDA | 2015-08-05 |
| Terminated | 2015-12-08 |
| Distributed | Nationwide (US) |
| Quantity | 1,283 kits |
| Reason classes | labeling |
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 for recall
Acon Laboratories, Inc. is recalling Mission Breath Alcohol Detector due to a labeling amendment.
Machine access
This record, with every extracted code, the verbatim FDA record and provenance, is available from the recall API: GET https://api.data.aroqon.com/v1/recalls/Z-2322-2015. Look up any UPC, UDI, NDC or lot with /v1/recalls/lookup?code=…. API docs · free and paid keys.
Source: U.S. Food and Drug Administration enforcement report via openFDA (CC0). Structured by Data Foundry (recall-structuring@2); last changed 2026-09-26. Not affiliated with or endorsed by FDA. Not medical or legal advice.