FDA Device recall Z-2322-2015
Mission -Breath Alcohol Detector -15 tests - 0.08% BAC - Blow bags included Product Usage: The Breath Alcohol Detector is for the semi-quan…
- FDA Device
- Class III
- terminated
- Published 2015-08-05
On 2015-08-05 the FDA classified a Class III recall of Mission -Breath Alcohol Detector -15 tests - 0.08% BAC - Blow bags included Product Usage: The Breath Alcohol Detector is for the semi-quan… by Acon Laboratories, citing acon Laboratories, Inc. is recalling Mission Breath Alcohol Detector due to a labeling amendment.
Read the official FDA Device notice
| Agency | FDA Device |
|---|---|
| Recall number | Z-2322-2015 |
| Classification | Class III |
| Status | terminated |
| Initiated | 2015-06-17 |
| Published | 2015-08-05 |
| Last updated | 2026-09-13 11:53 UTC |
| Company | Acon Laboratories |
| Distribution | US |
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.
Identifiers
| code_info | -BAD4040003 (48 kits) -BAD4080006 (59 kits) -BAD5010010/BAD5040013/BAD5010011 (total of 1,176 kits) |
|---|
Status history
No status changes recorded since RecallRadar first saw this recall on 2026-09-13 11:53 UTC. Current status: terminated.
Source
Official record: https://api.fda.gov/device/enforcement.json?search=recall_number:%22Z-2322-2015%22
RecallRadar indexes public recall notices from the FDA, USDA FSIS, and CPSC. The official agency notice is the authoritative source. Always confirm details at the linked source before acting.