{
  "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": "2026-04-22",
    "results": {
      "skip": 0,
      "limit": 1,
      "total": 1
    }
  },
  "results": [
    {
      "status": "Terminated",
      "city": "San Diego",
      "state": "CA",
      "country": "United States",
      "classification": "Class III",
      "openfda": {},
      "product_type": "Devices",
      "event_id": "66394",
      "recalling_firm": "Alere San Diego, Inc.",
      "address_1": "9975 Summers Ridge Rd",
      "address_2": "N/A",
      "postal_code": "92121-2997",
      "voluntary_mandated": "Voluntary: Firm initiated",
      "initial_firm_notification": "Two or more of the following: Email, Fax, Letter, Press Release, Telephone, Visit",
      "distribution_pattern": "Worldwide Distribution - USA (nationwide) and countries of: South Africa and Canada.",
      "recall_number": "Z-0053-2014",
      "product_description": "Alere Triage¿ TOX Drug Screen Control 1    Product Generic Name: Quality Control Material    Description of the product:  Good Laboratory Practice suggests that external controls should be tested with each new lot or shipment  of test materials, or every 30 days, and as otherwise required by a laboratory\u0019s standard quality control  procedures. The Alere Triage¿ Drug Screen Controls, when used in accordance with the test procedures  described in the Alere Triage¿ TOX Drug Screen package insert, provide this capability. The results  obtained for the controls are to be compared with the assigned values given on the Expected Values Card,  accompanying the package insert, to determine if the procedure is within control limits.  Alere Triage¿ TOX Drug Screen Control 1 or Alere Triage¿ TOX Drug Screen Control 2 consist of  human urine matrix containing parent compounds and/or major metabolites/analogues of drugs of abuse.    510(k)/IDE/PMA number: K060788    Type of Packaging: 5 vials per level in a labeled kit box.    Indications for use: The Alere Triage¿ TOX Drug Screen Controls are to be used with the Alere Triage¿ TOX Drug Screen tests and Alere Triage¿ Meters to assist the laboratory in monitoring test performance.",
      "product_quantity": "38",
      "reason_for_recall": "Alere San Diego, Inc. initiated a voluntary recall of Alere Triage TOX Drug Screen Control 1 (PN 94413, Lot C2681A) because the CODE CHIP that was provided with this lot causes the control to fail when run in the QC Sample Mode using Alere Triage TOX Drug Screeen products. The Alere Triage TOX Drug Screen test devices and patient results are not affected.",
      "recall_initiation_date": "20130923",
      "center_classification_date": "20131023",
      "termination_date": "20140926",
      "report_date": "20131030",
      "code_info": "Part Number 94413.  Lot Number C2681A."
    }
  ]
}