{
  "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": "72597",
      "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 and the countries of  Puerto Rico, and foreign distribution to: Argentina, Australia, Brazil, Canada, Chile, China, Colombia, England, France, Germany, India, Israel, Italy, Japan, Kenya, Mexico, Panama, Philippines, Poland, Romania, Russia, Singapore, Spain, Taiwan, Turkey, and  Venezuela.",
      "recall_number": "Z-0643-2016",
      "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, Software Version 2.8 and below, 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": "VITROS 5,1: Domestic - 932, Foreign - 1245; 5,1 Refurbished: Domestic - 63; Foreign - 153",
      "reason_for_recall": "Software anomaly may allow VITROS Systems to sample and process assays while the fluids and reagent temperatures are not in the required temperature range for optimal processing. When this intermittent issue occurs, the VITROS Systems continue to operate and process results without notification to the User, possibly producing erroneous results.",
      "recall_initiation_date": "20151103",
      "center_classification_date": "20160113",
      "termination_date": "20180530",
      "report_date": "20160120",
      "code_info": "Software Version 2.8 and below;  VITROS 5,1 FS Chemistry System Serial Numbers J34000016 - 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, 34001311, 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, 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."
    }
  ]
}