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  "name": "Product Name: Lumipulse G pTau217/B-Amyloid 1-42 Plasma Ratio  Model/Catalog Number: CL0073  Software Version: Not Applicable  Product Description: Lumipulse G pTau217/¿-Amyloid 1-42 Plasma Ratio is an in vitro diagnostic (IVD) test that combines the test results of the Lumipulse G pTau 217 Plasma assay and the Lumipulse G ¿-Amyloid 1-42-N Plasma assay from the same patient specimen (K2EDTA plasma sample) into a numerical ratio. The Lumipulse G pTau 217/¿-Amyloid 1-42 Plasma Ratio Instructions For Use (IFU), CL0072, contains instructions on how to manually calculate the ratio and is supplied with each individual Lumipulse G assay.    Lumipulse G pTau217/¿-Amyloid 1-42 Plasma Ratio, Item# CL0073   is comprised of the following kits, which are imported:  Kit Description, Item#:  Imported from Fujirebio Europe (FRE):  Lumipulse G pTau 217 Plasma Immunoreaction Cartridges 81550  Lumipulse G pTau 217 Plasma Calibrators set 81557  Lumipulse pTau 217 Plasma Controls 81558  Lumipulse ¿-Amyloid Plasma Controls 81559    Imported from Fujirebio Japan (FRI):  Lumipulse G ¿-Amyloid 1-42-N Plasma Immunoreaction Cartridges 235447  Lumipulse G ¿-Amyloid 1-42-N Plasma Calibrators set 235454  Component: No",
  "description": "FDA recall Z-1301-2026 — Fujirebio Diagnostics, Inc. is recalling Product Name: Lumipulse G pTau217/B-Amyloid 1-42 Plasma Ratio  Model/Catalog Number: CL0073  Software Version: Not Applicable  Product Description: Lumipulse G pTau217/¿-Amyloid 1-42 Plasma Ratio is an in vitro diagnostic (IVD) test that combines the test results of the Lumipulse G pTau 217 Plasma assay and the Lumipulse G ¿-Amyloid 1-42-N Plasma assay from the same patient specimen (K2EDTA plasma sample) into a numerical ratio. The Lumipulse G pTau 217/¿-Amyloid 1-42 Plasma Ratio Instructions For Use (IFU), CL0072, contains instructions on how to manually calculate the ratio and is supplied with each individual Lumipulse G assay.    Lumipulse G pTau217/¿-Amyloid 1-42 Plasma Ratio, Item# CL0073   is comprised of the following kits, which are imported:  Kit Description, Item#:  Imported from Fujirebio Europe (FRE):  Lumipulse G pTau 217 Plasma Immunoreaction Cartridges 81550  Lumipulse G pTau 217 Plasma Calibrators set 81557  Lumipulse pTau 217 Plasma Controls 81558  Lumipulse ¿-Amyloid Plasma Controls 81559    Imported from Fujirebio Japan (FRI):  Lumipulse G ¿-Amyloid 1-42-N Plasma Immunoreaction Cartridges 235447  Lumipulse G ¿-Amyloid 1-42-N Plasma Calibrators set 235454  Component: No (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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    "@type": "schema:MedicalDevice",
    "name": "Product Name: Lumipulse G pTau217/B-Amyloid 1-42 Plasma Ratio  Model/Catalog Number: CL0073  Software Version: Not Applicable  Product Description: Lumipulse G pTau217/¿-Amyloid 1-42 Plasma Ratio is an in vitro diagnostic (IVD) test that combines the test results of the Lumipulse G pTau 217 Plasma assay and the Lumipulse G ¿-Amyloid 1-42-N Plasma assay from the same patient specimen (K2EDTA plasma sample) into a numerical ratio. The Lumipulse G pTau 217/¿-Amyloid 1-42 Plasma Ratio Instructions For Use (IFU), CL0072, contains instructions on how to manually calculate the ratio and is supplied with each individual Lumipulse G assay.    Lumipulse G pTau217/¿-Amyloid 1-42 Plasma Ratio, Item# CL0073   is comprised of the following kits, which are imported:  Kit Description, Item#:  Imported from Fujirebio Europe (FRE):  Lumipulse G pTau 217 Plasma Immunoreaction Cartridges 81550  Lumipulse G pTau 217 Plasma Calibrators set 81557  Lumipulse pTau 217 Plasma Controls 81558  Lumipulse ¿-Amyloid Plasma Controls 81559    Imported from Fujirebio Japan (FRI):  Lumipulse G ¿-Amyloid 1-42-N Plasma Immunoreaction Cartridges 235447  Lumipulse G ¿-Amyloid 1-42-N Plasma Calibrators set 235454  Component: No",
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      "@id": "https://drug-device-safety-atlas.ryanjhunter.workers.dev/recalls/Z-1301-2026/enforcement-record",
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      "name": "FDA recall Z-1301-2026: Fujirebio Diagnostics, Inc. is recalling Product Name: Lumipulse G pTau217/B-Amyloid 1-42 Plasma Ratio  Model/Catalog Number: CL0073  Software Version: Not Applicable  Product Description: Lumipulse G pTau217/¿-Amyloid 1-42 Plasma Ratio is an in vitro diagnostic (IVD) test that combines the test results of the Lumipulse G pTau 217 Plasma assay and the Lumipulse G ¿-Amyloid 1-42-N Plasma assay from the same patient specimen (K2EDTA plasma sample) into a numerical ratio. The Lumipulse G pTau 217/¿-Amyloid 1-42 Plasma Ratio Instructions For Use (IFU), CL0072, contains instructions on how to manually calculate the ratio and is supplied with each individual Lumipulse G assay.    Lumipulse G pTau217/¿-Amyloid 1-42 Plasma Ratio, Item# CL0073   is comprised of the following kits, which are imported:  Kit Description, Item#:  Imported from Fujirebio Europe (FRE):  Lumipulse G pTau 217 Plasma Immunoreaction Cartridges 81550  Lumipulse G pTau 217 Plasma Calibrators set 81557  Lumipulse pTau 217 Plasma Controls 81558  Lumipulse ¿-Amyloid Plasma Controls 81559    Imported from Fujirebio Japan (FRI):  Lumipulse G ¿-Amyloid 1-42-N Plasma Immunoreaction Cartridges 235447  Lumipulse G ¿-Amyloid 1-42-N Plasma Calibrators set 235454  Component: No",
      "text": "The FDA logged enforcement record Z-1301-2026: Fujirebio Diagnostics, Inc. is voluntarily recalling Product Name: Lumipulse G pTau217/B-Amyloid 1-42 Plasma Ratio  Model/Catalog Number: CL0073  Software Version: Not Applicable  Product Description: Lumipulse G pTau217/¿-Amyloid 1-42 Plasma Ratio is an in vitro diagnostic (IVD) test that combines the test results of the Lumipulse G pTau 217 Plasma assay and the Lumipulse G ¿-Amyloid 1-42-N Plasma assay from the same patient specimen (K2EDTA plasma sample) into a numerical ratio. The Lumipulse G pTau 217/¿-Amyloid 1-42 Plasma Ratio Instructions For Use (IFU), CL0072, contains instructions on how to manually calculate the ratio and is supplied with each individual Lumipulse G assay.    Lumipulse G pTau217/¿-Amyloid 1-42 Plasma Ratio, Item# CL0073   is comprised of the following kits, which are imported:  Kit Description, Item#:  Imported from Fujirebio Europe (FRE):  Lumipulse G pTau 217 Plasma Immunoreaction Cartridges 81550  Lumipulse G pTau 217 Plasma Calibrators set 81557  Lumipulse pTau 217 Plasma Controls 81558  Lumipulse ¿-Amyloid Plasma Controls 81559    Imported from Fujirebio Japan (FRI):  Lumipulse G ¿-Amyloid 1-42-N Plasma Immunoreaction Cartridges 235447  Lumipulse G ¿-Amyloid 1-42-N Plasma Calibrators set 235454  Component: No — reason: Customers may experience inaccurate test results by observing a higher frequency of classification in the indeterminate and positive zone and/or low specificity when compared back to FDA-cleared CSF ratio/PET imaging, due to falsely elevated positive ratio or falsely elevated indeterminate ratio results causing an incorrect classification of a patient as having amyloid pathology associated with Alzheimer s disease (positive result) and/or requiring more clinical testing of that patient (indeterminate result).. Status: Ongoing — the recall is still being carried out.. Initiated 2025-12-11. Affected lots/codes: Model/Catalog Number: CL0073; UDI-DI: 00869164000086; Distribution for Lumipulse G pTau217/B-Amyloid 1-42 Plasma Ratio (\"Ratio\") is related to the \"Ratio\" Instructions for Use (IFU). Therefore, each consignee has 1 \"Ratio\" in which they purchase the component kits for.. A RECORDED FDA enforcement action (occurred=true).",
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        "value": "Devices recall, status Ongoing",
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          "url": "https://www.accessdata.fda.gov/scripts/enforcement/enforce_rpt-Product-Tabs.cfm?action=select&recall_number=Z-1301-2026&lang=eng"
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      "falsifier": "A RECORD of measured/reported events (occurred=true) from openFDA drug & device enforcement (recall) reports — U.S. FDA; superseded when openFDA drug & device enforcement (recall) reports — U.S. FDA publishes its next release."
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      "name": "FDA classified recall Z-1301-2026 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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        "value": "Class II",
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      "falsifier": "occurred=FALSE: a regulatory DETERMINATION (an authority's classification/judgment) has NO material truthmaker independent of recognition — it is constituted by U.S. FDA recall classification (openFDA enforcement)'s say-so (a Searle institutional fact), not measured. adjudged=TRUE because U.S. FDA recall classification (openFDA enforcement) (an external authority) issued it. Distinct from a recorded measurement (which has an independent truthmaker) and from a modeled figure (a computed quantity, not a verdict). Challengeable; superseded if the authority reclassifies."
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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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        "value": "a recorded enforcement action, not proof of harm or causation; not medical advice",
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      "falsifier": "occurred=FALSE (a framing, not an event) and adjudged=FALSE (an in-house reading, not an authority's verdict) — the LOWEST-warrant claim here. A flat representation would render this identically to the official facts; the four-status does not."
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            "Status": "recorded"
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            "Field": "Classification",
            "Value": "Class II",
            "Status": "determination"
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            "Field": "Status",
            "Value": "Ongoing — the recall is still being carried out.",
            "Status": "recorded"
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          "item": {
            "Field": "Recalling firm",
            "Value": "Fujirebio Diagnostics, Inc.",
            "Status": "recorded"
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            "Field": "Reason",
            "Value": "Customers may experience inaccurate test results by observing a higher frequency of classification in the indeterminate and positive zone and/or low specificity when compared back to FDA-cleared CSF ratio/PET imaging, due to falsely elevated positive ratio or falsely elevated indeterminate ratio results causing an incorrect classification of a patient as having amyloid pathology associated with Alzheimer s disease (positive result) and/or requiring more clinical testing of that patient (indeterminate result).",
            "Status": "recorded"
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            "Field": "Initiated",
            "Value": "2025-12-11",
            "Status": "recorded"
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            "Field": "Lot/code info",
            "Value": "Model/Catalog Number: CL0073; UDI-DI: 00869164000086; Distribution for Lumipulse G pTau217/B-Amyloid 1-42 Plasma Ratio (\"Ratio\") is related to the \"Ratio\" Instructions for Use (IFU). Therefore, each consignee has 1 \"Ratio\" in which they purchase the component kits for.",
            "Status": "recorded"
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          "item": {
            "Field": "Distribution pattern",
            "Value": "US Nationwide distribution in the states of Arizona, California, Florida, Indiana, Kansas, Kentucky, Maryland, Massachusetts, Minnesota, New Jersey, Pennsylvania, Texas, Washington.",
            "Status": "recorded"
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