Acon Laboratories, Inc.
FDA adverse event reports naming Acon Laboratories, Inc. as the device manufacturer, with recall history from the live FDA recall database. Reporter-supplied name as filed: ACON LABORATORIES, INC..
- Total reports
- 1,576
- Deaths
- 0
- Injuries
- 24
- Malfunctions
- 1,550
Reports per year
Source: FDA adverse event reports by year received, 2015–2026. Reporting paused during the 2026 MAUDE-to-AEMS transition and has since resumed.
Top device categories
- Coronavirus Antigen Detection Test System.QKP1,329
- Covid-19 Multi-Analyte Antigen DeviceQMN149
- Multi-Analyte Respiratory Virus Antigen Detection TestSCA39
- Automated Urinalysis SystemKQO24
- Over-The-Counter Covid-19 Antigen TestQYT13
- System, Test, Blood Glucose, Over The CounterNBW12
- Diazonium Colorimetry, Urobilinogen (Urinary, Non-Quant.)CDM3
- Test, Urine LeukocyteLJX3
- Refractometer For Clinical UseJRE2
- Single Use Only Blood Lancet With An Integral Sharps Injury Prevention FeatureFMK1
Recent recalls
- 2015-07-30TerminatedLabeling False and Misleading
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.
Acon Laboratories, Inc. is recalling Mission Breath Alcohol Detector due to a labeling amendment.
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