{
  "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": "Portage",
      "state": "MI",
      "country": "United States",
      "classification": "Class III",
      "openfda": {},
      "product_type": "Devices",
      "event_id": "62572",
      "recalling_firm": "Phadia US Inc",
      "address_1": "4169 Commercial Ave",
      "address_2": "N/A",
      "postal_code": "49002-9701",
      "voluntary_mandated": "Voluntary: Firm initiated",
      "initial_firm_notification": "Letter",
      "distribution_pattern": "USA Nationwide.",
      "recall_number": "Z-2285-2012",
      "product_description": "PHADIA Varelisa Cardiolipin IgM  Cardiolipin autoantibody immunological test system (IgM class antibodies)",
      "product_quantity": "837 kits (96 assays per kit), total of 80,352 individual assays",
      "reason_for_recall": "Customers were not following the labeled assay procedure. This was due to a letter issued to them in 2004 from Phadia GmbH, which indicated that customers could omit the pre-wash step. The omission of the pre-wash step, when combined with a change in material source in kit lot #0067, caused elevated results.",
      "recall_initiation_date": "20120802",
      "center_classification_date": "20120828",
      "termination_date": "20121212",
      "report_date": "20120905",
      "code_info": "Article Number 15696  Lot number #0067"
    }
  ]
}