{
  "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": "Terminated",
      "city": "Athens",
      "state": "OH",
      "country": "United States",
      "classification": "Class II",
      "openfda": {},
      "product_type": "Devices",
      "event_id": "79629",
      "recalling_firm": "Diagnostic Hybrids, Inc.",
      "address_1": "2005 E State St Ste 100",
      "address_2": "N/A",
      "postal_code": "45701-2125",
      "voluntary_mandated": "Voluntary: Firm initiated",
      "initial_firm_notification": "Letter",
      "distribution_pattern": "The products were distributed to the following US states: NY, TX, CO, UT.  The products were distributed to the following foreign countries: Switzerland.",
      "recall_number": "Z-1496-2018",
      "product_description": "MicroVue CIC-C1q EIA, Model A001.  An enzyme immunoassay for the detection of circulating immune complexes in human serum or plasma.  The assay uses highly pure, functional human C1q coated in the solid phase to capture immune complexes (CIC). In the first stage, CIC in the diluted patient samples and HAGG in the controls and standards are dispensed into the C1q coated assay wells. After incubation, unbound material is removed in a washing step and a ready to use conjugate (goat anti-human Ig-HRP) is added. After a second incubation, unbound conjugate is washed away. After addition of a substrate and a short incubation interval, the quantity of CIC in the sample (¿g Eq/ml) can be determined by comparison to a standard curve.",
      "product_quantity": "101 kits",
      "reason_for_recall": "There is a potential for the slope of the standard curve to fail to meet the assay validation requirements for the assay.",
      "recall_initiation_date": "20170404",
      "center_classification_date": "20180424",
      "termination_date": "20200828",
      "report_date": "20180502",
      "code_info": "Lot 084007"
    }
  ]
}