{
  "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": "The Alere Cholestech LDX¿ hsCRP  cassette (PN 12-807) may have increased imprecision relative to the performance data in the package insert,  which may cause differences in quantitative results for hsCRP compared to a reference method or  repeat testing on the same patient sample.",
      "address_2": "",
      "product_quantity": "2333 kits",
      "code_info": "Model Number 12-807.  ¿ Lot/Unit Codes: 274632, 281847  ¿ Expiration date, or Expected shelf life: 5/5/13, 6/30/13",
      "center_classification_date": "20130425",
      "distribution_pattern": "USA Nationwide Distribution",
      "state": "CA",
      "product_description": "The Alere Cholestech LDX¿ high sensitivity C-Reactive Protein (hsCRP) Test Cassette, Model Number 12-807.       Product Usage:    Immunoassay for the determination of C-Reactive Protein (CRP). The Alere Cholestech LDX¿ high sensitivity C-Reactive Protein (hsCRP) is an in vitro diagnostic test for the quantitative determination of C-reactive protein in whole blood or serum.",
      "report_date": "20130501",
      "classification": "Class II",
      "openfda": {},
      "recalling_firm": "Alere San Diego, Inc.",
      "recall_number": "Z-1178-2013",
      "initial_firm_notification": "Two or more of the following: Email, Fax, Letter, Press Release, Telephone, Visit",
      "product_type": "Devices",
      "event_id": "64701",
      "termination_date": "20140312",
      "more_code_info": "",
      "recall_initiation_date": "20130306",
      "postal_code": "92121-2997",
      "voluntary_mandated": "Voluntary: Firm initiated",
      "status": "Terminated"
    }
  ]
}