{
  "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": "2026-04-15",
    "results": {
      "skip": 0,
      "limit": 1,
      "total": 1
    }
  },
  "results": [
    {
      "status": "Ongoing",
      "city": "Garden Grove",
      "state": "CA",
      "country": "United States",
      "classification": "Class II",
      "openfda": {},
      "product_type": "Devices",
      "event_id": "83268",
      "recalling_firm": "Hycor Biomedical Inc",
      "address_1": "7272 Chapman Ave",
      "address_2": "N/A",
      "postal_code": "92841-2103",
      "voluntary_mandated": "Voluntary: Firm initiated",
      "initial_firm_notification": "Letter",
      "distribution_pattern": "Worldwide distribution to US state of TX , Netherlands, Belgium, Austria, Italy, and India",
      "recall_number": "Z-2200-2019",
      "product_description": "HYTEC 288 System, Model 74007P, automated immunoanalyzer (EIA) instrument. For in vitro diagnostic use only.      HYTEC AUTOSTAT II RF assays: HYTEC AUTOSTAT II RF IgM Kit: Part Number FGA 05, HYTEC AUTOSTAT II RF IgA Kit: Part Number FGA 06, HYTEC AUTOSTAT II RF IgG Kit: Part Number FGA 07, HYTEC AUTOSTAT II Total Rheumatoid Factor Kit: Part Number FGA 08.",
      "product_quantity": "288",
      "reason_for_recall": "Reports when using Rheumatoid Factor test kits, control and negative samples may be  elevated following a sample containing high levels of IgG . The negative control may report out of range; a negative sample may recover as a low positive  which could contribute to an incorrect or premature diagnosis of rheumatoid.",
      "recall_initiation_date": "20180319",
      "center_classification_date": "20190806",
      "report_date": "20190814",
      "code_info": "All lots of RF assay"
    }
  ]
}