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.
The agency’s classification
FDA (Devices): Class III
Class III is a situation in which use of or exposure to a violative product is not likely to cause adverse health consequences.
This is the agency’s own classification, taken from its notice. The severity score below is our assessment, not the agency’s. How recall classes work
What this means for you
Our assessment, not the agency’s: severity 1/5 (Low).
Cosmetic or documentation issue. No expected health impact, but the manufacturer is correcting the affected products.
Our severity reasoning: The recall is for a labeling amendment, which falls under the 'packaging-only problems' or 'documentation issues' criteria for a Low severity score.
Plain-English summary
Acon Laboratories, Inc. is recalling 1,283 kits of the Mission Breath Alcohol Detector. The recall is being conducted due to a labeling amendment. The product is a semi-quantitative rapid detection device for the presence of alcohol in exhaled breath, indicated for relative Blood Alcohol Concentration (BAC) at various cut-off levels.
The affected products were distributed nationwide in the states of New York, California, Florida, Virginia, Louisiana, New Jersey, Minnesota, Pennsylvania, Michigan, Ohio, Texas, Utah, Alabama, and Georgia. Specific lot codes involved in the recall include BAD4040003, BAD4080006, BAD5010010, BAD5040013, and BAD5010011.
The source text does not specify the exact nature of the labeling error or provide specific instructions for consumers beyond the recall notice. Consumers should check their product packaging for the affected lot codes and contact the manufacturer for further information.
The recalled product
- 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…
- Manufacturer
- Acon Laboratories, Inc.
- Hazard
- Affected units
- 1,283
Is your product affected?
Check your packaging against the codes below. If any of them match, the product is part of this recall.
Lot numbers (1)
- 176 kits)
Distribution
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