{
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  "cite_as": "Cal 3 CAL2351, Randox Laboratories, Ltd. deviCERTS medical device catalogue. https://devicerts.com/devices/cal-3-cal2351 (data as of 2026-11-15).",
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    "registry_records_last_synced": "2026-11-07",
    "status_as_of": "2026-11-15",
    "license": "CC BY 4.0",
    "license_url": "https://creativecommons.org/licenses/by/4.0/",
    "license_scope": "The deviCERTS layout and text are licensed under CC BY 4.0. Registry data remain under their source terms: U.S. FDA data (openFDA, AccessGUDID) are U.S. public domain; EUDAMED data are subject to the European Commission reuse terms.",
    "attribution": "DevicErts, https://devicerts.com/devices/cal-3-cal2351",
    "disclaimer": "Compiled by deviCERTS (devicerts.com) from public medical device registries (EUDAMED, European Commission; U.S. FDA via openFDA; AccessGUDID, U.S. National Library of Medicine). deviCERTS is not an official register and gives no regulatory advice: the record in the registry itself prevails."
  },
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    "url": "https://devicerts.com/devices/cal-3-cal2351",
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        "code": "W0101050301",
        "term": "CALIBRATORS MULTICOMPONENT (CC)"
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    {
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      "date": "2006-01-13",
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      "decision_code": "SESE",
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      "withdrawn": null,
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    }
  ],
  "no_longer_listed_by": [],
  "certificates": [],
  "recalls": [
    {
      "number": "Z-1759-2024",
      "classification": "Class II",
      "status": "ongoing",
      "initiated": "2024-03-05",
      "reason": "Randox Laboratories has identified that Inorganic Phosphate in Calibration Serum Level 3, CAL2351 & CAL10388, is running with a negative bias on RX Series instruments compared to other methods.",
      "applies": "this device",
      "via": "K053153"
    },
    {
      "number": "Z-0753-2024",
      "classification": "Class II",
      "status": "ongoing",
      "initiated": "2023-11-20",
      "reason": "Target for Alkaline Phosphatase (ALP) for the AMP\noptimized to IFCC 37C method has been mis-assigned for the RX Series instruments by approximately 10% on Quality Control and patient samples",
      "applies": "this device",
      "via": "K053153"
    },
    {
      "number": "Z-0752-2024",
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      "status": "ongoing",
      "initiated": "2023-11-20",
      "reason": "CK Total in Calibration Serum Level 3, CAL2351, is running with a positive bias on RX Series instruments compared to other methods experience a shift in Quality Control and patient sample recovery of up to 13%.",
      "applies": "this device",
      "via": "K053153"
    },
    {
      "number": "Z-0751-2024",
      "classification": "Class II",
      "status": "ongoing",
      "initiated": "2023-11-13",
      "reason": "There have been transcription errors on the Instructions For Use (IFU) of the Calibration Serum\nLevel 3 (CAL2351 lot 1260UE, 1262UE and 1315UE) for target values of Bilirubin and Triglycerides, on the\nIFU of Human Assayed Multi-Sera Level 2 (HN1530) for TBIC taget value and on IFU of Human Assayed\nMulti-Sera Level 3 (HE 1532) for Lipase target value.",
      "applies": "this device",
      "via": "K053153"
    },
    {
      "number": "Z-1563-2021",
      "classification": "Class II",
      "status": "terminated",
      "initiated": "2021-03-29",
      "reason": "Randox can confirm a positive bias for Total Bilirubin and Direct Bilirubin of up to +15% across the assay ranges when using calibrator CAL2351, lot 1162UE. The positive bias has been attributed to bilirubin instability in the calibrator and is evident in both Quality Control (QC) and Patient samples.",
      "applies": "this device",
      "via": "K053153"
    },
    {
      "number": "Z-2490-2019",
      "classification": "Class III",
      "status": "terminated",
      "initiated": "2019-07-12",
      "reason": "Randox Laboratories realigned RX Analyser Series calibration targets by 10% for AST and 9% for ALT in line with the Mean of All Instrument method target for the Randox Calibration Serum Level 3 (for calibrator lot 961UE onwards).",
      "applies": "this device",
      "via": "K053153"
    }
  ],
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