{
  "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": [
    {
      "country": "United States",
      "city": "Redmond",
      "address_1": "6565 185th Ave NE",
      "reason_for_recall": "Prolonged exposure of the MONOLISA Anti-HBs EIA Conjugate Diluent component to light may result in elevated Optical Densities (OD) in some samples such that a negative sample could elevate to a grey zone or low positive result.",
      "address_2": "",
      "product_quantity": "7,400 (approximately)- All lots since distribution date May 9, 2007",
      "code_info": "All lots distributed from May 5, 2007",
      "center_classification_date": "20120917",
      "distribution_pattern": "Worldwide distribution: USA (nationwide) and countries of:  Canada, South Africa, and Zimbabwe.",
      "state": "WA",
      "product_description": "The Bio-Rad MONOLISA Anti-HBs EIA is for In Vitro Diagnostic Use and it has the catalog number 25220.  It is a qualitative and quantitative enzyme immunoassay for the detection of antibody for hepatitis B surface antigen in human serum and EDTA or citrated plasma.      The Bio-Rad MONOLISA Anti-HBs EIA is a qualitative and quantitative enzyme immunoassay for the detection of antibody for hepatitis B surface antigen in human serum and EDTA or citrated plasma. The assay results may be used as an aid in the determination of susceptibility to hepatitis B virus (HBV) infection in individuals prior to or following HBV vaccination or where vaccination status is unknown. Assay results may be used with other HBV serological markers for the laboratory diagnosis of HBV disease associated with HBV infection.",
      "report_date": "20120926",
      "classification": "Class II",
      "openfda": {},
      "recalling_firm": "Bio-Rad Laboratories",
      "recall_number": "Z-2398-2012",
      "initial_firm_notification": "Letter",
      "product_type": "Devices",
      "event_id": "62850",
      "termination_date": "20121214",
      "more_code_info": "",
      "recall_initiation_date": "20120727",
      "postal_code": "98052-5039",
      "voluntary_mandated": "Voluntary: Firm initiated",
      "status": "Terminated"
    }
  ]
}