{
  "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": "68230",
      "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": "Nationwide Distribution only.",
      "recall_number": "Z-1727-2014",
      "product_description": "Alere Triage¿ D-Dimer Test  PN 98100, Lot W53884B.  The Alere Triage¿ D-Dimer Test is a fluorescence immunoassay to be used with the Alere Triage¿ Meters for the quantitative determination of cross-linked fibrin degradation products containing D-dimer in EDTA anticoagulated whole blood and plasma specimens.  .  The Alere Triage¿ D-Dimer test is intended for use as an aid in the assessment and evaluation of patients suspected of having disseminated intravascular coagulation or thromboembolic events including pulmonary embolism.",
      "product_quantity": "373 kits",
      "reason_for_recall": "Alere initiated this recall because a limited number of Alere Triage¿ D-Dimer devices from PN 98100 Lot W53884B were incorrectly manufactured.  As a result, when testing patient sample these affected devices will either generate an error code (e.g. E4 error), or they may generate an incorrect result.",
      "recall_initiation_date": "20140502",
      "center_classification_date": "20140606",
      "termination_date": "20150227",
      "report_date": "20140618",
      "code_info": "PN 98100, Lot W53884B."
    }
  ]
}