The Recall Desk

Manufacturer

Acon Laboratories, Inc.

1 recall in our database name Acon Laboratories, Inc. as the manufacturing or recalling firm.

What the numbers show

Total
1
Critical
0
Severe
0
Most recent
2015-08-05

Of the 1 recalls from Acon Laboratories, Inc. we have scored against our rubric, 0 (0%) are Critical — deaths or serious injuries reported, or the agency’s own highest classification — and 0 (0%) are Severe.

About this listing

The manufacturer string comes from the agency’s own source notice — for FDA recalls, the “recalling firm” field; for NHTSA recalls, the vehicle manufacturer; for CPSC recalls, the firm-of-record on the joint press release. A single corporate family can appear under multiple manufacturer strings as agency notices aren’t standardized on a canonical name. If you don’t see recalls you expect, try a parent-company search or a broader full-text search.

Severity scores below are computed from the agency’s classification and the recall text, never from manufacturer behaviour or history. Many manufacturers issue routine corrective actions (software updates, labelling corrections) that are correctly scored low — having recalls on this list isn’t inherently a quality signal.

1–1 of 1

  • LowFDA (Devices)·Z-2322-2015·2015-08-05

    Acon Recalls Mission Breath Alcohol Detector Kits for Labeling Amendment

    Acon Laboratories is recalling 1,283 Mission Breath Alcohol Detector kits due to a labeling amendment. The devices are distributed nationwide.

    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 Al
    Category
    Medical Device
    Distribution
    Distributed nationwide