FDAClass IIIAugust 5, 2015

Mission -Breath Alcohol Detector -15 tests - 0.08% BAC recall: Labeling Error

Mission -Breath Alcohol Detector -15 tests - 0.08% BAC - Blow bags included Product Usage: The Breath Alcohol Detector is for the semi-quantitative…

Why was Mission -Breath Alcohol Detector -15 tests - 0.08% BAC recalled?

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

What should I do if I have this product?

Review the official FDA enforcement record for current instructions.

What to do with a recalled product: refunds, receipts, safe disposal and how to report a problem.

Is my product affected?

Compare the item in your hand with every identifier below from the official FDA record. Only products that match the listed product and lot, UPC or model codes are part of this recall.

Which lot codes, UPCs or models are affected?

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

Product
Mission -Breath Alcohol Detector -15 tests - 0.08% BAC - Blow bags included Product Usage: The Breath Alcohol Detector is for the semi-quantitative…
Recalling firm
Acon Laboratories, Inc.
Quantity
1,283 kits
Distribution
U.S. Nationwide Distribution in the states of: NY, CA, FL, VA, LA, NJ, MN, PA, MI, OH, TX, VA, UT, AL, and GA
Recall date
August 5, 2015
Classification
Class III
Status
Terminated
Agency
FDA (device)
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