Class III — Acon Laboratories, Inc.
| Recalling firm | ACON Laboratories Inc. |
|---|---|
| Registered facility | View this company's 2 registered facilities → (openFDA recall records do not name a specific facility) |
| Classification | Class III |
| Status | Terminated |
| Reason | Acon Laboratories, Inc. is recalling Mission Breath Alcohol Detector due to a labeling amendment. |
| 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. |
| Quantity | 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 |
| Initiated | 2015-06-17 |
| Classified | 2015-07-30 |
| Terminated | 2015-12-08 |
| Recall number | Z-2322-2015 |
| Initiation | Voluntary: Firm initiated |
Source: U.S. FDA via openFDA (opens in a new tab) (device registration & enforcement). Data as of 2026-10-06. Verify this recall record at FDA → (opens in a new tab)
Cite this record
RegWarden. “Class III recall — Acon Laboratories, Inc. (Z-2322-2015).” Compiled from U.S. FDA public records (openFDA; FDA Data Dashboard). Data as of 2026-10-06. https://regwarden.com/recall/71550/
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