{
  "meta": {
    "disclaimer": "Do not rely on openFDA to make decisions regarding medical care. While we make every effort to ensure that data is accurate, you should assume all results are unvalidated. We may limit or otherwise restrict your access to the API in line with our Terms of Service.",
    "terms": "https://open.fda.gov/terms/",
    "license": "https://open.fda.gov/license/",
    "last_updated": "2026-08-13",
    "results": {
      "skip": 0,
      "limit": 1,
      "total": 1
    }
  },
  "results": [
    {
      "cfres_id": "138181",
      "product_res_number": "Z-2322-2015",
      "event_date_initiated": "2015-06-17",
      "event_date_posted": "2015-07-30",
      "recall_status": "Terminated",
      "event_date_terminated": "2015-12-08",
      "res_event_number": "71550",
      "product_code": "DJZ",
      "k_numbers": [
        "K093143"
      ],
      "product_description": "Mission \r\n-Breath Alcohol Detector\r\n\r\n-15 tests\r\n- 0.08% BAC\r\n- Blow bags included\r\n\r\nProduct Usage:\r\nThe 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.",
      "code_info": "-BAD4040003 (48 kits) -BAD4080006 (59 kits) -BAD5010010/BAD5040013/BAD5010011 (total of 1,176 kits)",
      "firm_fei_number": "3003516723",
      "recalling_firm": "Acon Laboratories, Inc.",
      "address_1": "10125 Mesa Rim Rd",
      "city": "San Diego",
      "state": "CA",
      "postal_code": "92121-2915",
      "additional_info_contact": "858-875-8000",
      "reason_for_recall": "Acon Laboratories, Inc. is recalling Mission Breath Alcohol Detector due to a labeling amendment.",
      "root_cause_description": "Labeling False and Misleading",
      "action": "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.\r\n\r\nThe contact noted in the letter is Qiyi Xie MD, MPH, Sr. Officer Regulatory and Clinical Affairs at 858-857-8011.",
      "product_quantity": "1,283 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",
      "openfda": {
        "k_number": [
          "K102338",
          "K071067",
          "K041334",
          "K052448",
          "K100879",
          "K062545",
          "K102225",
          "K090067",
          "K123470",
          "K052804",
          "K062971",
          "K043188",
          "K053332",
          "K063443",
          "K091714",
          "K160613",
          "K060761",
          "K072953",
          "K090766",
          "K081855",
          "K082086",
          "K080848",
          "K093143",
          "K110614",
          "K082080",
          "K083801",
          "K061922",
          "K060343"
        ],
        "registration_number": [
          "",
          "3030648160",
          "2087572",
          "3004077604",
          "3014059993",
          "3003483691",
          "3010763671",
          "3004847291",
          "3013019743",
          "3017676696",
          "3043127647",
          "3003309980",
          "3042256563",
          "3009348423",
          "3007037208",
          "3009585529",
          "3003917514",
          "3012275122",
          "3045964603",
          "3009312584",
          "3007343307",
          "3012073813",
          "3003383868",
          "1649661",
          "3013585270",
          "3004848020",
          "3027519599",
          "3007798866",
          "3042276415",
          "3016159411",
          "3004144955",
          "3045892220",
          "3010160538",
          "3002956991",
          "3013036322",
          "3014302776",
          "3012725363",
          "3030453686",
          "2030633",
          "1000655211",
          "3002653540",
          "3011119387",
          "1054127",
          "1832216",
          "9617268"
        ],
        "fei_number": [
          "",
          "3030648160",
          "3004077604",
          "3014059993",
          "1000112835",
          "3003483691",
          "3010763671",
          "3004847291",
          "3013019743",
          "3017676696",
          "3043127647",
          "3003309980",
          "3042256563",
          "3009348423",
          "3007037208",
          "3009585529",
          "3003917514",
          "3012275122",
          "3045964603",
          "3009312584",
          "3007343307",
          "3012073813",
          "3003383868",
          "3013585270",
          "3000140642",
          "3004848020",
          "3027519599",
          "3007798866",
          "3042276415",
          "3016159411",
          "3004144955",
          "3045892220",
          "3010160538",
          "3002956991",
          "3013036322",
          "3014302776",
          "3012725363",
          "3030453686",
          "1000655211",
          "3002653540",
          "3011119387",
          "3001451797",
          "1000352675",
          "1832216",
          "3000210620"
        ],
        "device_name": "Devices, Breath Trapping, Alcohol",
        "medical_specialty_description": "Clinical Toxicology",
        "regulation_number": "862.3050",
        "device_class": "1"
      }
    }
  ]
}