{
  "companyId": "47771",
  "slug": "ortho-clinical-diagnostics-inc-47771",
  "name": "Ortho-Clinical Diagnostics, Inc.",
  "clearances": {
    "total": 142,
    "last12Months": 1,
    "first": "1997-10-22",
    "latest": "2025-10-29"
  },
  "medianReviewDays": 57,
  "productCodeCount": 77,
  "recalls": {
    "total": 354,
    "openLast12Months": 0,
    "recent": [
      {
        "resNumber": "Z-2559-2025",
        "productCode": "KHP",
        "status": "Open, Classified",
        "recallClass": "Class II",
        "initiated": "2025-07-29",
        "reason": "VITROS Chemistry Products LAC Slides on VITROS XT 3400 and VITROS XT 7600 Systems are experiencing an increased occurrence of calibration failure related to lots from coating 0130 and above with Condition Code TH4-63J during calibration, causing the delay of lac test results and potentially impact patient management. The issue was identified by QuidelOrtho through an increase in customer complaints compared to the historical baseline with average failure rate of 1% for coating 0130 in 2025 while average of failure rate for other coating was 0.06% in 2025 and average of failure rate for all coatings is 0.03% for 2024."
      },
      {
        "resNumber": "Z-2560-2025",
        "productCode": "KHP",
        "status": "Open, Classified",
        "recallClass": "Class II",
        "initiated": "2025-07-29",
        "reason": "VITROS Chemistry Products LAC Slides on VITROS XT 3400 and VITROS XT 7600 Systems are experiencing an increased occurrence of calibration failure related to lots from coating 0130 and above with Condition Code TH4-63J during calibration, causing the delay of lac test results and potentially impact patient management. The issue was identified by QuidelOrtho through an increase in customer complaints compared to the historical baseline with average failure rate of 1% for coating 0130 in 2025 while average of failure rate for other coating was 0.06% in 2025 and average of failure rate for all coatings is 0.03% for 2024."
      },
      {
        "resNumber": "Z-2335-2025",
        "productCode": "CJY",
        "status": "Open, Classified",
        "recallClass": "Class II",
        "initiated": "2025-07-09",
        "reason": "Generations 67 and above of VITROS Ca Slides are experiencing an increased occurrence of Condition Code TH4-63J during calibration on VITROS XT 3400 and VITROS XT 7600 Systems, causing calibration failures that delay calcium test results and potentially impact patient management. The imaging reflectometer algorithm detects excessive \"spikes\" (imperfections) in slide images and generates the TH4-63J condition code when the threshold of 600 spikes is exceeded. Updated analysis revealed a 19-fold increase in failure rates from 0.0043% (2024 baseline) to 0.082% for Generation 67+ slides in 2025, with 100% of calibrator failures occurring at the lowest concentration level. This can result in delayed diagnosis and treatment of conditions such as hypercalcemic crisis, parathyroid disorders, and other calcium-related emergencies requiring urgent intervention."
      },
      {
        "resNumber": "Z-2073-2025",
        "productCode": "DJG",
        "status": "Open, Classified",
        "recallClass": "Class II",
        "initiated": "2025-06-12",
        "reason": "Lots from Generation (GEN) 15 of VITROS Chemistry Products OP Reagent may generate lower than expected quality control (QC) results. If the customer is unable to get passing quality control results, then the customer would be unable to run the OP-LO protocol leading to a potential delay in patient results."
      },
      {
        "resNumber": "Z-2120-2025",
        "productCode": "DIH",
        "status": "Open, Classified",
        "recallClass": "Class II",
        "initiated": "2025-06-10",
        "reason": "Quality control (QC) drift when certain lots of Performance Verifiers (PVs) are used with certain lots of cholinesterase enzyme (CHE) slides. This drift occurs when the PVs are used 2-7 days after reconstitution; however, the label stability claims for the PV fluids is 7 days following reconstitution. This may lead to inaccurate QC results. The use of the PVs when the QC results are outside of the customer s established ranges could result in delayed results for patients due to the need to repeat QC testing or reconstitute new PV fluids and repeat testing. It could also result in erroneous patient results (small positive bias)."
      }
    ]
  },
  "registration": {
    "sites": 9,
    "countries": [
      "US"
    ]
  },
  "productCodes": [
    {
      "code": "JJX",
      "deviceName": "Single (Specified) Analyte Controls (Assayed And Unassayed)",
      "clearances": 13,
      "latest": "2004-09-27",
      "medianReviewDays": 28
    },
    {
      "code": "MMI",
      "deviceName": "Immunoassay Method, Troponin Subunit",
      "clearances": 6,
      "latest": "2025-10-29",
      "medianReviewDays": 85
    },
    {
      "code": "JFY",
      "deviceName": "Enzymatic Method, Creatinine",
      "clearances": 5,
      "latest": "2018-10-30",
      "medianReviewDays": 23
    },
    {
      "code": "JJY",
      "deviceName": "Multi-Analyte Controls, All Kinds (Assayed)",
      "clearances": 5,
      "latest": "1999-08-24",
      "medianReviewDays": 28
    },
    {
      "code": "JIT",
      "deviceName": "Calibrator, Secondary",
      "clearances": 4,
      "latest": "2017-05-16",
      "medianReviewDays": 45
    },
    {
      "code": "JIX",
      "deviceName": "Calibrator, Multi-Analyte Mixture",
      "clearances": 4,
      "latest": "2016-05-20",
      "medianReviewDays": 18
    },
    {
      "code": "CGZ",
      "deviceName": "Electrode, Ion-Specific, Chloride",
      "clearances": 3,
      "latest": "2018-10-30",
      "medianReviewDays": 90
    },
    {
      "code": "DCK",
      "deviceName": "C-Reactive Protein, Antigen, Antiserum, And Control",
      "clearances": 3,
      "latest": "2017-07-14",
      "medianReviewDays": 28
    },
    {
      "code": "DHX",
      "deviceName": "System, Test, Carcinoembryonic Antigen",
      "clearances": 3,
      "latest": "2023-08-23",
      "medianReviewDays": 71
    },
    {
      "code": "JIS",
      "deviceName": "Calibrator, Primary",
      "clearances": 3,
      "latest": "2003-08-13",
      "medianReviewDays": 19
    },
    {
      "code": "KHS",
      "deviceName": "Enzymatic, Carbon-Dioxide",
      "clearances": 3,
      "latest": "2012-10-24",
      "medianReviewDays": 143
    },
    {
      "code": "CDD",
      "deviceName": "Radioassay, Vitamin B12",
      "clearances": 2,
      "latest": "2002-01-24",
      "medianReviewDays": 50
    },
    {
      "code": "CDN",
      "deviceName": "Urease, Photometric, Urea Nitrogen",
      "clearances": 2,
      "latest": "2019-03-14",
      "medianReviewDays": 29
    },
    {
      "code": "CEM",
      "deviceName": "Electrode, Ion Specific, Potassium",
      "clearances": 2,
      "latest": "2009-02-27",
      "medianReviewDays": 29
    },
    {
      "code": "CEW",
      "deviceName": "Radioimmunoassay, Parathyroid Hormone",
      "clearances": 2,
      "latest": "2023-09-05",
      "medianReviewDays": 105
    },
    {
      "code": "CGA",
      "deviceName": "Glucose Oxidase, Glucose",
      "clearances": 2,
      "latest": "2019-04-03",
      "medianReviewDays": 30
    },
    {
      "code": "CGN",
      "deviceName": "Acid, Folic, Radioimmunoassay",
      "clearances": 2,
      "latest": "2000-05-02",
      "medianReviewDays": 12
    },
    {
      "code": "CGR",
      "deviceName": "Radioimmunoassay, Cortisol",
      "clearances": 2,
      "latest": "2006-07-03",
      "medianReviewDays": 50
    },
    {
      "code": "CIX",
      "deviceName": "Bromcresol Green Dye-Binding, Albumin",
      "clearances": 2,
      "latest": "2019-06-07",
      "medianReviewDays": 19
    },
    {
      "code": "CJY",
      "deviceName": "Azo Dye, Calcium",
      "clearances": 2,
      "latest": "2007-09-24",
      "medianReviewDays": 21
    },
    {
      "code": "DHA",
      "deviceName": "System, Test, Human Chorionic Gonadotropin",
      "clearances": 2,
      "latest": "2024-05-08",
      "medianReviewDays": 115
    },
    {
      "code": "DLZ",
      "deviceName": "Enzyme Immunoassay, Phenobarbital",
      "clearances": 2,
      "latest": "2021-08-13",
      "medianReviewDays": 56
    },
    {
      "code": "JGS",
      "deviceName": "Electrode, Ion Specific, Sodium",
      "clearances": 2,
      "latest": "2009-09-03",
      "medianReviewDays": 41
    },
    {
      "code": "JHX",
      "deviceName": "Fluorometric Method, Cpk Or Isoenzymes",
      "clearances": 2,
      "latest": "2022-01-28",
      "medianReviewDays": 21
    },
    {
      "code": "JLW",
      "deviceName": "Radioimmunoassay, Thyroid-Stimulating Hormone",
      "clearances": 2,
      "latest": "2008-12-22",
      "medianReviewDays": 56
    }
  ],
  "productCodesShown": 25,
  "productCodesTotal": "77",
  "recentClearances": [
    {
      "kNumber": "K252393",
      "deviceName": "VITROS Immunodiagnostic Products hs Troponin I Reagent Pack",
      "productCode": "MMI",
      "decisionDate": "2025-10-29",
      "reviewDays": 90
    },
    {
      "kNumber": "K241534",
      "deviceName": "VITROS Immunodiagnostic Products Syphilis Reagent Pack",
      "productCode": "LIP",
      "decisionDate": "2024-08-28",
      "reviewDays": 90
    },
    {
      "kNumber": "K233581",
      "deviceName": "VITROS Immunodiagnostic Products Total ß-hCG II Reagent Pack",
      "productCode": "DHA",
      "decisionDate": "2024-05-08",
      "reviewDays": 183
    },
    {
      "kNumber": "K221197",
      "deviceName": "VITROS Immunodiagnostic Products Intact PTH II Reagent Pack",
      "productCode": "CEW",
      "decisionDate": "2023-09-05",
      "reviewDays": 498
    },
    {
      "kNumber": "K231517",
      "deviceName": "VITROS Immunodiagnostic Products CEA Reagent Pack",
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      "reviewDays": 90
    },
    {
      "kNumber": "K231525",
      "deviceName": "VITROS Immunodiagnostic Products CA 19-9TM Reagent Pack",
      "productCode": "NIG",
      "decisionDate": "2023-08-09",
      "reviewDays": 75
    },
    {
      "kNumber": "K221355",
      "deviceName": "VITROS Immuodiagnostic Products CA 125 II Reagent Pack",
      "productCode": "LTK",
      "decisionDate": "2022-12-12",
      "reviewDays": 216
    },
    {
      "kNumber": "K213626",
      "deviceName": "VITROS AFP",
      "productCode": "LOJ",
      "decisionDate": "2022-06-15",
      "reviewDays": 210
    },
    {
      "kNumber": "K212648",
      "deviceName": "VITROS Immunodiagnostic Products CK-MB Reagent Pack",
      "productCode": "JHX",
      "decisionDate": "2022-01-28",
      "reviewDays": 158
    },
    {
      "kNumber": "K201312",
      "deviceName": "VITROS Immunodiagnostic Products NT-proBNP II Reagent Pack",
      "productCode": "NBC",
      "decisionDate": "2021-10-04",
      "reviewDays": 504
    }
  ],
  "nameVariants": {
    "total": "21",
    "shown": [
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        "name": "ORTHO-CLINICAL DIAGNOSTICS",
        "dataset": "device/recall",
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      {
        "name": "Ortho Clinical Diagnostics",
        "dataset": "device/registrationlisting",
        "method": "normalised"
      },
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      },
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        "name": "Ortho Clinical Diagnostics Inc",
        "dataset": "device/recall",
        "method": "normalised"
      }
    ]
  },
  "sources": {
    "clearances": "https://api.fda.gov/device/510k.json?search=applicant%3A%22Ortho-Clinical%20Diagnostics%2C%20Inc.%22",
    "recalls": "https://api.fda.gov/device/recall.json?search=recalling_firm%3A%22Ortho-Clinical%20Diagnostics%2C%20Inc.%22"
  },
  "provenance": [
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      "dataset": "device/510k",
      "loadedAt": "2026-08-10T19:40:09Z",
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  "retrievedAt": "2026-08-11T14:48:53.034Z"
}