{
  "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 II",
      "openfda": {},
      "product_type": "Devices",
      "event_id": "65048",
      "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": "Letter",
      "distribution_pattern": "United States Nationwide Distribution",
      "recall_number": "Z-1401-2013",
      "product_description": "Alere\" hCG Combo Cassette (20/10 mIU/mL) Kit.      Product Usage:  The AlereTM hCG Combo (20/10 mIU/mL) test is a rapid chromatographic immunoassay for the qualitative detection of human chorionic gonadotropin (hCG) in serum or urine, as an aid in the early detection of pregnancy. It is for healthcare professionals only.",
      "product_quantity": "3975 kits",
      "reason_for_recall": "The firm initiated recall of Alere\" hCG Combo Cassette (20/10 mIU/mL) kit PN 92215, lots hCG1110133 and hCG1110135, because an investigation has indicated a portion of these Alere\" hCG Combo Cassette (20/10 mIU/mL) PN 92215 kit lots were incorrectly packaged with the Alere\" hCG Cassette (20 mIU/mL) PN 92210 Product Insert. The Alere\" hCG Cassette (20 mIU/mL) Product Insert contains information for",
      "recall_initiation_date": "20130416",
      "center_classification_date": "20130524",
      "termination_date": "20131018",
      "report_date": "20130605",
      "code_info": "Lot/Unit Codes: hCG1110133 & hCG1110135    Part Number: 92215    Expiration date, or Expected shelf life: 9/30/13 & 10/31/13"
    }
  ]
}