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  "name": "Product Name: Lumipulse pTau 217 Plasma Controls  Model/Catalog Number: 81558  Software Version: Not Applicable  Product Description: Lumipulse pTau 217 Plasma Controls:  This quality control product can be used as an objective judgement of the laboratory s procedures and personnel techniques when analyzing pTau 217 in K2EDTA plasma on the LUMIPULSE G System. It is a valuable tool to assess good laboratory practices. Two levels of control are available to compare observations with expected ranges therefore assuring consistent performance of the testing system within the clinical range.    Lumipulse pTau 217 Plasma Controls: Liquid (Frozen),  2 ¿2 Concentrations  L1     Level 1 (2¿ 1.5 mL)  L2     Level 2 (2¿ 1.5 mL)  Contains Tris buffer with protein (bovine) and chemical stabilizers. Preservative:  0.1% ProClin 300, 0.05% ProClin 950  Component: Yes. Lumipulse G pTau217/B-Amyloid 1-42 Plasma Ratio",
  "description": "FDA recall Z-1304-2026 — Fujirebio Diagnostics, Inc. is recalling Product Name: Lumipulse pTau 217 Plasma Controls  Model/Catalog Number: 81558  Software Version: Not Applicable  Product Description: Lumipulse pTau 217 Plasma Controls:  This quality control product can be used as an objective judgement of the laboratory s procedures and personnel techniques when analyzing pTau 217 in K2EDTA plasma on the LUMIPULSE G System. It is a valuable tool to assess good laboratory practices. Two levels of control are available to compare observations with expected ranges therefore assuring consistent performance of the testing system within the clinical range.    Lumipulse pTau 217 Plasma Controls: Liquid (Frozen),  2 ¿2 Concentrations  L1     Level 1 (2¿ 1.5 mL)  L2     Level 2 (2¿ 1.5 mL)  Contains Tris buffer with protein (bovine) and chemical stabilizers. Preservative:  0.1% ProClin 300, 0.05% ProClin 950  Component: Yes. Lumipulse G pTau217/B-Amyloid 1-42 Plasma Ratio (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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  "dateModified": "2026-06-24T07:02:03.626072+00:00",
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    "name": "Product Name: Lumipulse pTau 217 Plasma Controls  Model/Catalog Number: 81558  Software Version: Not Applicable  Product Description: Lumipulse pTau 217 Plasma Controls:  This quality control product can be used as an objective judgement of the laboratory s procedures and personnel techniques when analyzing pTau 217 in K2EDTA plasma on the LUMIPULSE G System. It is a valuable tool to assess good laboratory practices. Two levels of control are available to compare observations with expected ranges therefore assuring consistent performance of the testing system within the clinical range.    Lumipulse pTau 217 Plasma Controls: Liquid (Frozen),  2 ¿2 Concentrations  L1     Level 1 (2¿ 1.5 mL)  L2     Level 2 (2¿ 1.5 mL)  Contains Tris buffer with protein (bovine) and chemical stabilizers. Preservative:  0.1% ProClin 300, 0.05% ProClin 950  Component: Yes. Lumipulse G pTau217/B-Amyloid 1-42 Plasma Ratio",
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      "@id": "https://drug-device-safety-atlas.ryanjhunter.workers.dev/recalls/Z-1304-2026/enforcement-record",
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      "name": "FDA recall Z-1304-2026: Fujirebio Diagnostics, Inc. is recalling Product Name: Lumipulse pTau 217 Plasma Controls  Model/Catalog Number: 81558  Software Version: Not Applicable  Product Description: Lumipulse pTau 217 Plasma Controls:  This quality control product can be used as an objective judgement of the laboratory s procedures and personnel techniques when analyzing pTau 217 in K2EDTA plasma on the LUMIPULSE G System. It is a valuable tool to assess good laboratory practices. Two levels of control are available to compare observations with expected ranges therefore assuring consistent performance of the testing system within the clinical range.    Lumipulse pTau 217 Plasma Controls: Liquid (Frozen),  2 ¿2 Concentrations  L1     Level 1 (2¿ 1.5 mL)  L2     Level 2 (2¿ 1.5 mL)  Contains Tris buffer with protein (bovine) and chemical stabilizers. Preservative:  0.1% ProClin 300, 0.05% ProClin 950  Component: Yes. Lumipulse G pTau217/B-Amyloid 1-42 Plasma Ratio",
      "text": "The FDA logged enforcement record Z-1304-2026: Fujirebio Diagnostics, Inc. is voluntarily recalling Product Name: Lumipulse pTau 217 Plasma Controls  Model/Catalog Number: 81558  Software Version: Not Applicable  Product Description: Lumipulse pTau 217 Plasma Controls:  This quality control product can be used as an objective judgement of the laboratory s procedures and personnel techniques when analyzing pTau 217 in K2EDTA plasma on the LUMIPULSE G System. It is a valuable tool to assess good laboratory practices. Two levels of control are available to compare observations with expected ranges therefore assuring consistent performance of the testing system within the clinical range.    Lumipulse pTau 217 Plasma Controls: Liquid (Frozen),  2 ¿2 Concentrations  L1     Level 1 (2¿ 1.5 mL)  L2     Level 2 (2¿ 1.5 mL)  Contains Tris buffer with protein (bovine) and chemical stabilizers. Preservative:  0.1% ProClin 300, 0.05% ProClin 950  Component: Yes. Lumipulse G pTau217/B-Amyloid 1-42 Plasma Ratio — 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: 81558; UDI-DI: 05414470815586; Lot Numbers: D6C6092U, D6C6092U1, D6C6123U;. A RECORDED FDA enforcement action (occurred=true).",
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      "name": "FDA classified recall Z-1304-2026 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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      "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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      "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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      "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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            "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.",
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