{
  "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": [
    {
      "country": "United States",
      "city": "Rochester",
      "address_1": "100 Indigo Creek Dr",
      "reason_for_recall": "The reagent pack exhibits the potential for an increased frequency of calibration failures.",
      "address_2": "",
      "product_quantity": "6630",
      "code_info": "Lot 2601, 2610, 2620",
      "center_classification_date": "20181106",
      "distribution_pattern": "Worldwide Distribution: US (nationwide)  to the following US states:  AL, AR, AZ, CA, CO, CT, DC, FL, GA, IA, ID, IL, IN, KS, KY, LA, MA, MD, ME, MO, MS, MT, NC, NE, NJ, NM, NV, NY, OH, OK, PA, SC, SD, TN, TX, VT, WA, WI, WV, and WY; and countries of:  Belgium, Bermuda, Brazil, Canada, Chile, Columbia, Denmark, France, Germany, India, Italy, Portugal, Spain, and UK.",
      "state": "NY",
      "product_description": "VITROS Immunodiagnostic Products Vitamin B12 Reagent Pack 1/2, Catalog Number 1453489    For in vitro diagnostic use only For the quantitative measurement of vitamin B12 in human serum and plasma (EDTA or heparin) using the VITROS ECi/ECiQ Immunodiagnostic Systems, the VITROS 3600 Immunodiagnostic System and the VITROS 5600 Integrated System, to aid in the differential diagnosis of anemia",
      "report_date": "20181114",
      "classification": "Class II",
      "openfda": {},
      "recalling_firm": "Ortho-Clinical Diagnostics",
      "recall_number": "Z-0392-2019",
      "initial_firm_notification": "Letter",
      "product_type": "Devices",
      "event_id": "81066",
      "termination_date": "20200811",
      "more_code_info": "",
      "recall_initiation_date": "20180828",
      "postal_code": "14626-5101",
      "voluntary_mandated": "Voluntary: Firm initiated",
      "status": "Terminated"
    }
  ]
}