{
  "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": "2026-04-01",
    "results": {
      "skip": 0,
      "limit": 1,
      "total": 1
    }
  },
  "results": [
    {
      "status": "Completed",
      "city": "Benicia",
      "state": "CA",
      "country": "United States",
      "classification": "Class II",
      "openfda": {},
      "product_type": "Devices",
      "event_id": "85074",
      "recalling_firm": "Bio-Rad Labs",
      "address_1": "5500 E 2nd St",
      "address_2": "N/A",
      "postal_code": "94510-1020",
      "voluntary_mandated": "Voluntary: Firm initiated",
      "initial_firm_notification": "Letter",
      "distribution_pattern": "US Nationwide distribution including the states of  AZ, NY, LA, FL, CA, TX, IA, MS, UT, and IL.",
      "recall_number": "Z-1800-2020",
      "product_description": "Autoimmune EIA Anti-Tissue Transglutaminase (tTG) IgA Test; Material Number 425-2260; Lot number 18200A - Product Usage: The assay is an aid in the diagnosis of celiac disease (gluten-sensitive enteropathy) and should be used in conjunction with other serological tests and clinical findings.",
      "product_quantity": "376 units",
      "reason_for_recall": "An elevated lot-to-lot bias was observed for Autoimmune EIA Anti-Tissue Transglutaminase (tTG) IgA when compared to a previous lot of product. The observed elevated bias between these two lots is largely due to samples with higher levels of antibodies. With the cut-off for the assay being 15 U/mL, the clinical classifications for most samples would remain unchanged.",
      "recall_initiation_date": "20190403",
      "center_classification_date": "20200424",
      "report_date": "20200506",
      "code_info": "Catalog Number 425-2260; Lot Number 18200A: UDI 00847817018336."
    }
  ]
}