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  "@id": "https://drug-device-safety-atlas.ryanjhunter.workers.dev/recalls/Z-0207-2024.jsonld",
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  "name": "Nova Biomedical Prime Plus Analyzer -Intended to measure certain gases in blood, serum, plasma or pH of blood, serum, and plasma.      (1) PN 57400 Stat Profile Prime Plus Analyzer  (2) PN 59508 Stat Profile Prime Plus Analyzer, Remanufactured",
  "description": "FDA recall Z-0207-2024 — Nova Biomedical Corporation is recalling Nova Biomedical Prime Plus Analyzer -Intended to measure certain gases in blood, serum, plasma or pH of blood, serum, and plasma.      (1) PN 57400 Stat Profile Prime Plus Analyzer  (2) PN 59508 Stat Profile Prime Plus Analyzer, Remanufactured (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.",
  "license": "https://creativecommons.org/publicdomain/zero/1.0/",
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  "dateModified": "2026-06-24T07:02:03.626072+00:00",
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    "name": "openFDA drug & device enforcement (recall) reports",
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    "creator": {
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  "sameAs": "https://www.accessdata.fda.gov/scripts/enforcement/enforce_rpt-Product-Tabs.cfm?action=select&recall_number=Z-0207-2024&lang=eng",
  "about": {
    "@type": "schema:MedicalDevice",
    "name": "Nova Biomedical Prime Plus Analyzer -Intended to measure certain gases in blood, serum, plasma or pH of blood, serum, and plasma.      (1) PN 57400 Stat Profile Prime Plus Analyzer  (2) PN 59508 Stat Profile Prime Plus Analyzer, Remanufactured",
    "manufacturer": {
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      "name": "Nova Biomedical Corporation"
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      "@id": "https://drug-device-safety-atlas.ryanjhunter.workers.dev/recalls/Z-0207-2024/enforcement-record",
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      "name": "FDA recall Z-0207-2024: Nova Biomedical Corporation is recalling Nova Biomedical Prime Plus Analyzer -Intended to measure certain gases in blood, serum, plasma or pH of blood, serum, and plasma.      (1) PN 57400 Stat Profile Prime Plus Analyzer  (2) PN 59508 Stat Profile Prime Plus Analyzer, Remanufactured",
      "text": "The FDA logged enforcement record Z-0207-2024: Nova Biomedical Corporation is voluntarily recalling Nova Biomedical Prime Plus Analyzer -Intended to measure certain gases in blood, serum, plasma or pH of blood, serum, and plasma.      (1) PN 57400 Stat Profile Prime Plus Analyzer  (2) PN 59508 Stat Profile Prime Plus Analyzer, Remanufactured — reason: Potential risk of reporting erroneous creatinine patient results associated with the initial start-up of a new BUN/Creatinine Sensor Cartridge. The potential risk is within the first 2-4 hours after cartridge installation that may not be identified by traditional Quality Control practices.. Status: Ongoing — the recall is still being carried out.. Initiated 2023-09-18. Affected lots/codes: UDI-DI:  (1) 00385480574006 (2) 00385480595087 All software versions (V1.17.1123.0 and V3.2.1123.0). A RECORDED FDA enforcement action (occurred=true).",
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      "epistemicStatus": {
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        "supported": true,
        "adjudged": true,
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        "sourceUrl": "https://www.accessdata.fda.gov/scripts/enforcement/enforce_rpt-Product-Tabs.cfm?action=select&recall_number=Z-0207-2024&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-0207-2024&lang=eng"
        }
      },
      "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."
    },
    {
      "@id": "https://drug-device-safety-atlas.ryanjhunter.workers.dev/recalls/Z-0207-2024/fda-classification",
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      "name": "FDA classified recall Z-0207-2024 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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          "name": "U.S. FDA recall classification (openFDA enforcement)",
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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."
    },
    {
      "@id": "https://drug-device-safety-atlas.ryanjhunter.workers.dev/recalls/Z-0207-2024/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.",
      "claimType": "interpretation",
      "reviewStatus": "current",
      "commercialInfluence": false,
      "epistemicStatus": {
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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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            "Field": "Reason",
            "Value": "Potential risk of reporting erroneous creatinine patient results associated with the initial start-up of a new BUN/Creatinine Sensor Cartridge. The potential risk is within the first 2-4 hours after cartridge installation that may not be identified by traditional Quality Control practices.",
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            "Field": "Distribution pattern",
            "Value": "Nationwide Foreign: Country Algeria Australia Austria Bangladesh Benin Bolivia Brazil Canada Chile China Colombia Croatia CYPRUS Czech Republic Ecuador Egypt El Salvador Finland France Germany Greece Guatemala India Indonesia Ireland Israel Italy Japan JORDAN Kazakhstan Kenya Kurdistan, Iraq Kuwait Malaysia Malta Mexico Moldova Morocco Nepal Netherlands New Zealand Oman Pakistan Palestine Paraguay Paraquay Peru Philippines Poland Puerto Rico Qatar Republic of Panama Romania Russia Rwanda Saudi Arabia Serbia Slovenia South Africa South Korea Spain Sri Lanka Sudan Sweden Switzerland Syria Thailand Trinidad Trinidad,W.I. Tunisia UK Ukraine United Arab Emerites Uruguay Vietnam",
            "Status": "recorded"
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