{
  "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": "Rochester",
      "state": "NY",
      "country": "United States",
      "classification": "Class II",
      "openfda": {},
      "product_type": "Devices",
      "event_id": "72979",
      "recalling_firm": "Ortho-Clinical Diagnostics",
      "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 including Puerto Rico, and the countries of Australia, Brazil, Canada, Chile, China, Colombia, England, France, Germany,  India, Italy, Japan, Mexico, Panama, Singapore, Spain, and  Venezuela",
      "recall_number": "Z-1075-2016",
      "product_description": "VITROS 5,1 FS Chemistry System, Catalog Number 6801375, Unique Device Identifier Number 10758750001132; and VITROS 5,1 FS Chemistry System (Refurbished), Catalog Number 6801890, Unique Device Identifier Number 10758750001644; IVD.    Product Usage:  The VITROS 5,1 FS Chemistry System is intended for use in the in vitro quantitative measurement of a variety of analytes of clinical interest, using both VITROS Chemistry Products Slides (colorimetric endpoint, rate, ion-selective electrode, and immunorate methods) and VITROS Chemistry Products MicroTip liquid reagents (spectrophotometric and spectrophotometric immunoassay methods.)",
      "product_quantity": "US = 994; Foreign = 1405",
      "reason_for_recall": "Increased U90-382 or 6LU condition codes generated by VITROS 250, 350, 5,1 FS, 4600 and 5600 Chemistry Systems when using Calibrator Kit 9, Lot 954.  A trend of complaints regarding customers actions following U90-382 or 6LU condition codes was noted (See RES 72289 - VITROS Calibrator Kit 9, lot 954 recall).",
      "recall_initiation_date": "20151221",
      "center_classification_date": "20160308",
      "termination_date": "20180530",
      "report_date": "20160316",
      "code_info": "Software Version 2.8 and below; VITROS 5,1 FS Chemistry System Serial Numbers: J34000119 - J34002323; VITROS 5,1 FS Chemistry System (Refurbished) Serial Numbers: 34000133, 34000193, 34000197, 34000212,   34000285, 34000316, 34000318, 34000337, 34000360, 34000420, 34000451,  34000478, 34000495, 34000497, 34000529, 34000538, 34000552, 34000557,   34000590, 34000596, 34000601, 34000631, 34000642, 34000761, 34000799,   34000805, 34000833, 34000851, 34000893, 34000946, 34000947, 34001006,   34001172, 34001218, 34001240, 34001243, 34001248, 34001251, 34001274,   34001297, 34001317, 34001345, 34001378, 34001379, 34001389, 34001390, 34001396, 34001422, 34001472, 34001504, 34001569, 34001572, 34001612, 34001626, 34001633, 34001668, 34001755, 34001809, 34001840, 34001850,   34001875, 34001897, 34000123, 34000143, 34000191, 34000215, 34000219,   34000235, 34000251, 34000256, 34000260, 34000261, 34000319, 34000331,  34000380, 34000382, 34000406, 34000408, 34000412, 34000426, 34000431,   34000454, 34000464, 34000473, 34000501, 34000523, 34000530, 34000541,   34000542, 34000546, 34000548, 34000553, 34000558, 34000576, 34000577,  34000584, 34000585, 34000609, 34000612, 34000615, 34000616, 34000617,   34000618, 34000620, 34000625, 34000637, 34000644, 34000672, 34000744,   34000745, 34000755, 34000759, 34000767, 34000776, 34000793, 34000800,  34000814, 34000831, 34000844, 34000846, 34000852, 34000856, 34000870,   34000876, 34000887, 34000892, 34000902, 34000912, 34000920, 34000938,   34000956, 34000969, 34000976, 34001007, 34001009, 34001044, 34001045,   34001052, 34001071, 34001075, 34001098, 34001099, 34001111, 34001129,   34001154, 34001161, 34001171, 34001182, 34001192, 34001195, 34001201,   34001204, 34001208, 34001212, 34001234, 34001247, 34001254, 34001271,   34001278, 34001284, 34001288, 34001289, 34001293, 34001298, 34001301,   34001302, 34001316, 34001325, 34001337, 34001340, 34001348, 34001367,   34001369, 34001399, 34001400, 34001407, 34001410, 34001416, 34001423,   34001427, 34001429, 34001457, 34001490, 34001518, 34001526, 34001551,  34001573, 34001580, 34001581, 34001582, 34001587, 34001589, 34001594,   34001610, 34001618, 34001623, 34001627, 34001673, 34001688, 34001693,   34001725, 34001738, 34001745, 34001747, 34001790, 34001796, 34001798,   34001810, 34001822, 34001831, 34001833, 34001849, 34001855, 34001859,   34001860, 34001867, 34001871, 34001872, 34001881, 34001905, 34001916,   34001923, 34001995"
    }
  ]
}