Reported Aug 5, 2015 · Terminated

Mission -Breath Alcohol Detector -15 tests - 0.08% BAC - Blow bags included Product Usage: The Breath Alcohol Detector…

Acon Laboratories, Inc.

Low riskThis product is unlikely to cause harm, but it breaks a safety or labelling rule.

What you should do

Stop using the affected lot and contact the recalling firm for the return or refund process. Check the FDA enforcement report for lot-level detail.

Firm contact: Acon Laboratories, Inc. · 10125 Mesa Rim Rd · San Diego, CA · 92121-2915

Is this the product you have?

  • Mission -Breath Alcohol Detector -15 tests - 0.08%
  • BAC - Blow bags included Product UsageThe 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
Lot codes and dates
  • -BAD4040003 (48 kits) -BAD4080006 (59 kits) -BAD5010010/BAD5040013/BAD5010011 (total of 1,176 kits)
Amount recalled
1,283 kits

Where it was sold

Why it was recalled

Acon Laboratories, Inc. is recalling Mission Breath Alcohol Detector due to a labeling amendment.

This product is unlikely to cause harm, but it breaks a safety or labelling rule.

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Where this came from

Source: U.S. Food & Drug Administration (openFDA)

Read the FDA (openFDA device enforcement) notice

Notice updated Dec 8, 2015 · Data as of Sep 19, 5:25 PM UTC

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