{
  "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": "Terminated",
      "city": "Rochester",
      "state": "NY",
      "country": "United States",
      "classification": "Class II",
      "openfda": {},
      "product_type": "Devices",
      "event_id": "87390",
      "recalling_firm": "Ortho-Clinical Diagnostics, Inc.",
      "address_1": "100 Indigo Creek Dr",
      "address_2": "N/A",
      "postal_code": "14626-5101",
      "voluntary_mandated": "Voluntary: Firm initiated",
      "initial_firm_notification": "Letter",
      "distribution_pattern": "Worldwide distribution - US Nationwide distribution and the countries of Australia, Belgium, Brazil, Canada L3R 4G5, Chile,   China, Colombia, Denmark, France, Germany, India, Italy, Japan, Mexico, Norway, Poland, Portugal, Russia, Singapore 609917, Spain, Sweden, The Netherlands, United Kingdom.",
      "recall_number": "Z-1295-2021",
      "product_description": "VITROS Chemistry Products Calibrator Kit 4-(Calibrator values for TIBC only).  Used to calibrate VITROS 250/350/5,1 FS/4600/XT 3400 Chemistry Systems and VITROS 5600/XT 7600 Integrated Systems     Product Code: 1204668    Impacted Products:  A. VITROS Chemistry Products TIBC Kit Product No: 7541  (UDI 8750005178)\tAll current and new lots  B. VITROS Chemistry Products Fe Slides   Product No: 1924547   90 Slides (UDI 10758750000289)   Product No: 1515808   300 slides   (UDI 10758750009244)  Product No: 6802198 (Japan)   90 Slides (UDI 10758750002276)    All current, new and previous lots",
      "product_quantity": "7546 US and 15280 OUS kits",
      "reason_for_recall": "Potential total iron-binding capacity (TIBC) results.  The VITROS TIBC performance shift will start with the newest Generation (GEN) of VITROS Fe Slides (GEN 26), the potential shift in TIBC patient values of GEN 26 and above will be approximately 80 ug/dL lower across the measuring range than other available GENS of VITROS Fe Slides (GENs 22-25).",
      "recall_initiation_date": "20210218",
      "center_classification_date": "20210323",
      "termination_date": "20221018",
      "report_date": "20210331",
      "code_info": "Lot Numbers:  0449 (exp. 28-Aug-2021)  0459 (exp. 10-Feb-2022)  0460 (exp. 01-Oct-2022)  UDI: (10758750008537)",
      "more_code_info": ""
    }
  ]
}