{
  "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": [
    {
      "country": "United States",
      "city": "San Diego",
      "address_1": "9975 Summers Ridge Rd",
      "reason_for_recall": "Certain lots of the affected products may have significantly decreased precision relative to the package insert, which could result in an increased frequency of false positive or false negative results. These false positive and false negative results are unpredictable within lots and may not be detected by Quality Control testing.",
      "address_2": "",
      "product_quantity": "5,013 kits",
      "code_info": "Phase 1:    K50708B, W50009B, W50011B, W50012B, W50013B, W50014B, W50016VB, W50021B,  W50026B, W50028B, W50030B, W50771B, W50772B, W50773B, W50774B, W50778B, and W50801B.    Phase 2:    W50015B, W50029B, and W50788B.",
      "center_classification_date": "20120706",
      "distribution_pattern": "Nationwide Distribution",
      "state": "CA",
      "product_description": "Alere Triage Profiler SOB Panel PN 97300    Used for the determination of creatine kinase MB, myoglobin, troponin I, B-type natriuretic peptide, and cross-linked fibrin degradation products containing D-dimer in EDTA anticoagulated whole blood and plasma specimens.",
      "report_date": "20120718",
      "classification": "Class I",
      "openfda": {},
      "recalling_firm": "Alere San Diego, Inc.",
      "recall_number": "Z-1930-2012",
      "initial_firm_notification": "Letter",
      "product_type": "Devices",
      "event_id": "61927",
      "termination_date": "20131018",
      "more_code_info": "",
      "recall_initiation_date": "20120522",
      "postal_code": "92121-2997",
      "voluntary_mandated": "Voluntary: Firm initiated",
      "status": "Terminated"
    }
  ]
}