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  "name": "VITROS Chemistry Products Ca Slides;  Catalog Number: 145 0261;",
  "description": "FDA recall Z-2335-2025 — Ortho-Clinical Diagnostics, Inc. is recalling VITROS Chemistry Products Ca Slides;  Catalog Number: 145 0261; (Devices, Class II). The enforcement record is RECORDED; the classification is a DETERMINATION (FDA's regulatory verdict); the boundary is INTERPRETATION (a recall ≠ harm to a specific person). Source: openFDA. CC0.",
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    "name": "VITROS Chemistry Products Ca Slides;  Catalog Number: 145 0261;",
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      "name": "FDA recall Z-2335-2025: Ortho-Clinical Diagnostics, Inc. is recalling VITROS Chemistry Products Ca Slides;  Catalog Number: 145 0261;",
      "text": "The FDA logged enforcement record Z-2335-2025: Ortho-Clinical Diagnostics, Inc. is voluntarily recalling VITROS Chemistry Products Ca Slides;  Catalog Number: 145 0261; — 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.. Status: Ongoing — the recall is still being carried out.. Initiated 2025-07-09. Affected lots/codes: Catalog Number: 145 0261; UDI-DI: 10758750009114; Affected GENs: 67 and above;. A RECORDED FDA enforcement action (occurred=true).",
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      "name": "FDA classified recall Z-2335-2025 as Class II",
      "text": "The FDA assigned this recall Class II: Class II — the FDA judged the product may cause temporary or medically reversible harm, with a remote chance of serious harm.. This is the FDA's official risk classification — its regulatory DETERMINATION of the hazard category (a verdict constituted by the FDA's recognition, occurred=FALSE), adjudged=TRUE because the FDA issued it. It is NOT a measurement of harm to any specific person.",
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      "@type": "schema:Claim",
      "name": "What an FDA recall is — and is NOT",
      "text": "A recall is a RECORDED FDA enforcement action — the FDA logged that a firm is removing or correcting a product, classed by the FDA's risk judgment. It does NOT establish that any specific unit is affected or caused harm; causation is not established. This record informs and compares — it is NOT medical advice and does not tell anyone to start or stop a drug or device. For a medical decision, route to the FDA recall record and a licensed pharmacist or prescriber.",
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            "Field": "Reason",
            "Value": "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.",
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