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Recall Observatory FDA recall evidence

Exact FDA event identifier

Event 71550

1 recalled-product record grouped only because every row carries this exact official event ID.

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Event summary

Timeline bucket
June 17, 2015
Product types
Device
Classifications
Class III
Statuses
Terminated
Recalling firm wording
Acon Laboratories, Inc.

Dossier provenance

Source snapshots represented here

  • openFDA Device Enforcement Report-date coverage June 20, 2012–July 08, 2026 Known gap: openFDA describes 2004-present coverage, but the current export has no report-date records in this interval.
  • openFDA Device Recall event_date_initiated coverage June 01, 1997–June 30, 2026

Enforcement coverage uses report dates; product initiation dates can precede those bounds. Device-enrichment coverage uses FDA event_date_initiated.

How coverage and grouping work

Complete imported group

Every recalled product in this event

1 official enforcement rows

Product dates, classifications, firms, and source wording remain attached to their individual rows. Opening this dossier never hides products that did not match a prior timeline filter.

device · product 1 of 1

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.

Z-2322-2015
Recall number
Z-2322-2015
Initiated
June 17, 2015
Classification
Class III
Status
Terminated
Recalling firm
Acon Laboratories, Inc.
Quantity
1,283 kits

App-derived interpretation

Unknown reason.no_named_rule · v1.0.0
Acon Laboratories, Inc. is recalling Mission Breath Alcohol Detector due to a labeling amendment.

These labels are deterministic app interpretations, not FDA categories.

Official device-enrichment evidence · Sourced

Labeling False and Misleading

Compare all device evidence states

Inspect official wording and provenance

Reason for recall

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

Code information

-BAD4040003 (48 kits) -BAD4080006 (59 kits) -BAD5010010/BAD5040013/BAD5010011 (total of 1,176 kits)

Distribution pattern

U.S. Nationwide Distribution in the states of: NY, CA, FL, VA, LA, NJ, MN, PA, MI, OH, TX, VA, UT, AL, and GA