{
  "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": "2026-04-29",
    "results": {
      "skip": 0,
      "limit": 1,
      "total": 1
    }
  },
  "results": [
    {
      "country": "United States",
      "city": "Rochester",
      "address_1": "100 Indigo Creek Dr",
      "reason_for_recall": "Software Anomaly; It is possible for the device to process samples with a cartridge other than the intended cartridge, potentially leading to erroneous patient results. If this anomaly occurred previously, an indication would be a series of results that were similar across multiple samples (i.e., results could be believable or outside of the Reportable Range for the intended assay).",
      "address_2": "",
      "product_quantity": "VITROS 5.1 System: Domestic - 909; Foreign - 1250; 5,1 Refurbished: Domestic - 66 units, Foreign - 152",
      "code_info": "Software Version 2.8 & Below; VITROS 5,1 FS Chemistry System Serial Numbers 34000119 - 34002323; VITROS 5,1 Refurbished: Serial Numbers - Domestic S/Ns: 34000133, 34000193, 34000197, 34000212, 34000285, 34000316, 34000318, 34000337, 34000360, 34000420, 34000451, 34000464, 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, 34001589, 34001610, 34001612, 34001626, 34001633, 34001668, 34001755, 34001809, 34001840, 34001850, 34001875, 34001897; Foreign S/Ns: 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, 34001071, 34001075, 34001098,   34001099, 34001111, 34001129, 34001154, 34001161, 34001171, 34001182,   34001204, 34001208, 34001212, 34001234, 34001247, 34001254, 34001271,   34001278, 34001284, 34001288, 34001289, 34001293, 34001298, 34001301,   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, 34001790, 34001796, 34001810, 34001822, 34001831, 34001833,   34001849, 34001855, 34001859, 34001860, 34001867, 34001871, 34001872,   34001881, 34001905, 34001916, 34001923, 34001995.  --- PLEASE NOTE: The serial numbers are sequential, but not all analyzers are released for distribution. Therefore, the amount of each system manufactured may not equal the amount of each system distributed.",
      "center_classification_date": "20150424",
      "distribution_pattern": "Worldwide Distribution -- USA, Puerto Rico,  Australia, Brazil, Canada, Chile, China, Colombia, England, France, Germany, India, Italy, Japan, Mexico, Republic of Panama, Singapore, Spain, and Venezuela.",
      "state": "NY",
      "product_description": "Software Version 2.8 & Below on VITROS 5,1 FS Chemistry Systems, Catalog Number 6801375, Global Trade Item Number 10758750001132, and VITROS 5,1 FS Chemistry System Refurbished, Catalog Number 6801890, Global Trade Item Number 10758750001644; IVD.    Intended for use in the in vitro quantitative, semi quantitative, and qualitative measurement of a variety of analytes of clinical interest, using VITROS Chemistry Products MicroSlides and VITROS Chemistry Products MicroTip Reagents.",
      "report_date": "20150506",
      "classification": "Class II",
      "openfda": {},
      "recalling_firm": "Ortho-Clinical Diagnostics",
      "recall_number": "Z-1521-2015",
      "initial_firm_notification": "Letter",
      "product_type": "Devices",
      "event_id": "70685",
      "termination_date": "20180601",
      "more_code_info": "",
      "recall_initiation_date": "20150310",
      "postal_code": "14626-5101",
      "voluntary_mandated": "Voluntary: Firm initiated",
      "status": "Terminated"
    }
  ]
}