{
  "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": "Brea",
      "state": "CA",
      "country": "United States",
      "classification": "Class II",
      "openfda": {},
      "product_type": "Devices",
      "event_id": "63152",
      "recalling_firm": "Beckman Coulter Inc.",
      "address_1": "250 S Kraemer Blvd",
      "address_2": "N/A",
      "postal_code": "92821-6232",
      "voluntary_mandated": "Voluntary: Firm initiated",
      "initial_firm_notification": "Letter",
      "distribution_pattern": "Worldwide distribution: USA (nationwide) and country of: Canada.",
      "recall_number": "Z-0003-2013",
      "product_description": "IMMAGE Immunochemistry Systems Rheumatoid Factor (RF) Reagent, PN 447070    The IMMAGE Immunochemistry Systems Rheumatoid Factor (RF) reagent, in conjunction with Beckman Cal 5 Plus, is intended for use in the quantitative determination of human rheumatoid factor concentrations in human serum and plasma samples by rate nephelometry. This assay is designed for use with the IMMAGE Immunochemistry System.",
      "product_quantity": "925 units",
      "reason_for_recall": "The recall was initiated because Beckman Coulter has confirmed customer reports of QC shifts, lot-to-lot variation, and an increase in the percent of patient samples recovering >20 IU/mL using the Lots# M012376 and M101865 of IMMAGE RF reagent.  The lots identified for the RF reagent might produce false abnormal results.",
      "recall_initiation_date": "20120127",
      "center_classification_date": "20121001",
      "termination_date": "20130530",
      "report_date": "20121010",
      "code_info": "Lot# M012376 and M101865"
    }
  ]
}