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  "@id": "https://drug-device-safety-atlas.ryanjhunter.workers.dev/recalls/Z-1249-2025.jsonld",
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  "name": "Access Erythropoietin (EPO), Catalog Number - A16364  a glycoprotein (~30,400 Daltons) produced primarily by the kidney, is the principal factor regulating red blood cell production (erythropoiesis)  in mammals. Renal production of EPO is regulated by changes in oxygen  availability. Under conditions of hypoxia, the level of EPO in the circulation  increases and this leads to increased production of red blood cells.",
  "description": "FDA recall Z-1249-2025 — Beckman Coulter, Inc. is recalling Access Erythropoietin (EPO), Catalog Number - A16364  a glycoprotein (~30,400 Daltons) produced primarily by the kidney, is the principal factor regulating red blood cell production (erythropoiesis)  in mammals. Renal production of EPO is regulated by changes in oxygen  availability. Under conditions of hypoxia, the level of EPO in the circulation  increases and this leads to increased production of red blood cells. (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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    "@type": "schema:MedicalDevice",
    "name": "Access Erythropoietin (EPO), Catalog Number - A16364  a glycoprotein (~30,400 Daltons) produced primarily by the kidney, is the principal factor regulating red blood cell production (erythropoiesis)  in mammals. Renal production of EPO is regulated by changes in oxygen  availability. Under conditions of hypoxia, the level of EPO in the circulation  increases and this leads to increased production of red blood cells.",
    "manufacturer": {
      "@type": "schema:Organization",
      "name": "Beckman Coulter, Inc."
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      "@id": "https://drug-device-safety-atlas.ryanjhunter.workers.dev/recalls/Z-1249-2025/enforcement-record",
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      "name": "FDA recall Z-1249-2025: Beckman Coulter, Inc. is recalling Access Erythropoietin (EPO), Catalog Number - A16364  a glycoprotein (~30,400 Daltons) produced primarily by the kidney, is the principal factor regulating red blood cell production (erythropoiesis)  in mammals. Renal production of EPO is regulated by changes in oxygen  availability. Under conditions of hypoxia, the level of EPO in the circulation  increases and this leads to increased production of red blood cells.",
      "text": "The FDA logged enforcement record Z-1249-2025: Beckman Coulter, Inc. is voluntarily recalling Access Erythropoietin (EPO), Catalog Number - A16364  a glycoprotein (~30,400 Daltons) produced primarily by the kidney, is the principal factor regulating red blood cell production (erythropoiesis)  in mammals. Renal production of EPO is regulated by changes in oxygen  availability. Under conditions of hypoxia, the level of EPO in the circulation  increases and this leads to increased production of red blood cells. — reason: Affected lot (439363) exhibited a negative dose drop of -22% with native patient samples compared to alternate reagent lots. Patient samples tested with the affected lot may demonstrate repeatable falsely decreased results, which may lead to improper diagnosis or repeat testing.. Status: Ongoing — the recall is still being carried out.. Initiated 2025-02-03. Affected lots/codes: Catalog A16364 UDI-DI 15099590201838 Lot 439363. A RECORDED FDA enforcement action (occurred=true).",
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        "adjudged": true,
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        "sourceUrl": "https://www.accessdata.fda.gov/scripts/enforcement/enforce_rpt-Product-Tabs.cfm?action=select&recall_number=Z-1249-2025&lang=eng",
        "value": "Devices recall, status Ongoing",
        "adjudicator": {
          "name": "openFDA drug & device enforcement (recall) reports — U.S. FDA",
          "url": "https://www.accessdata.fda.gov/scripts/enforcement/enforce_rpt-Product-Tabs.cfm?action=select&recall_number=Z-1249-2025&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-1249-2025 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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      "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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    {
      "@id": "https://drug-device-safety-atlas.ryanjhunter.workers.dev/recalls/Z-1249-2025/boundary",
      "@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",
        "adjudicator": null
      },
      "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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            "Value": "Beckman Coulter, Inc.",
            "Status": "recorded"
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            "Field": "Reason",
            "Value": "Affected lot (439363) exhibited a negative dose drop of -22% with native patient samples compared to alternate reagent lots. Patient samples tested with the affected lot may demonstrate repeatable falsely decreased results, which may lead to improper diagnosis or repeat testing.",
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            "Field": "Distribution pattern",
            "Value": "Domestic distribution to AL AR AZ CA CT FL ID IL IN KS MA MI NC NE NJ NY OH OR PA TN TX UT WA WV. International distribution to Argentina, Australia, Austria, Belgium, Brazil, Bulgaria, Canada, China, Czechia, Denmark, France, Germany, Hungary, India, Italy, Japan, Korea, Republic of, Netherlands, Philippines, Russian Federation, Saudi Arabia, Slovakia, Spain, United Kingdom of Great Britain and Northern Ireland",
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