Mission -Breath Alcohol Detector -15 tests - 0.08% BAC - Blow bags included Product Usage: The Breath Alcohol Detector i
FDA device recall Z-2322-2015 · posted 2015-07-30 · Terminated
Recall details
- Recalling firm
- Acon Laboratories, Inc.
- Reason for recall
- Acon Laboratories, Inc. is recalling Mission Breath Alcohol Detector due to a labeling amendment.
- Action taken
- On 06/17/15 the firm sent out customer notification letters to their distributors. The letter identified the affected product, problem and actions to be taken. In the letter the firm requests that Mission Breath Alcohol Detectors be quarantined. The firm asks that distributor complete the "fax back" form to allow for the return of unexpired product for a replacement. Once the form is received the firm is going to issue a return authorization number as well as provide a return label. The contact noted in the letter is Qiyi Xie MD, MPH, Sr. Officer Regulatory and Clinical Affairs at 858-857-8011.
- Root cause
- Labeling False and Misleading
- Status
- Terminated
- Product code
- DJZ
- Quantity affected
- 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
- Date initiated
- 2015-06-17
- Date posted
- 2015-07-30
- Date terminated
- 2015-12-08
- Location
- San Diego, CA
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Related 510(k) clearances
| Record | Firm | Date |
|---|---|---|
| MISSION BREATH ALCOHOL DETECTOR (K093143) | ACON Laboratories, Inc. | 2010-01-28 |