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  "@id": "https://drug-device-safety-atlas.ryanjhunter.workers.dev/recalls/Z-2153-2023.jsonld",
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  "name": "Simplexa Direct Amplification Disc Kit, Rx Only, IVD    The Simplexa Direct Amplification Disc Kit, REF: MOL1455 is 1 box containing 3 Direct Amplification Discs (DADs). Each box contains discs individually pouch-sealed and labeled with REF: MOL1452",
  "description": "FDA recall Z-2153-2023 — DiaSorin Molecular LLC is recalling Simplexa Direct Amplification Disc Kit, Rx Only, IVD    The Simplexa Direct Amplification Disc Kit, REF: MOL1455 is 1 box containing 3 Direct Amplification Discs (DADs). Each box contains discs individually pouch-sealed and labeled with REF: MOL1452 (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/",
  "isAccessibleForFree": true,
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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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  "sameAs": "https://www.accessdata.fda.gov/scripts/enforcement/enforce_rpt-Product-Tabs.cfm?action=select&recall_number=Z-2153-2023&lang=eng",
  "about": {
    "@type": "schema:MedicalDevice",
    "name": "Simplexa Direct Amplification Disc Kit, Rx Only, IVD    The Simplexa Direct Amplification Disc Kit, REF: MOL1455 is 1 box containing 3 Direct Amplification Discs (DADs). Each box contains discs individually pouch-sealed and labeled with REF: MOL1452",
    "manufacturer": {
      "@type": "schema:Organization",
      "name": "DiaSorin Molecular LLC"
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  "claims": [
    {
      "@id": "https://drug-device-safety-atlas.ryanjhunter.workers.dev/recalls/Z-2153-2023/enforcement-record",
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      "name": "FDA recall Z-2153-2023: DiaSorin Molecular LLC is recalling Simplexa Direct Amplification Disc Kit, Rx Only, IVD    The Simplexa Direct Amplification Disc Kit, REF: MOL1455 is 1 box containing 3 Direct Amplification Discs (DADs). Each box contains discs individually pouch-sealed and labeled with REF: MOL1452",
      "text": "The FDA logged enforcement record Z-2153-2023: DiaSorin Molecular LLC is voluntarily recalling Simplexa Direct Amplification Disc Kit, Rx Only, IVD    The Simplexa Direct Amplification Disc Kit, REF: MOL1455 is 1 box containing 3 Direct Amplification Discs (DADs). Each box contains discs individually pouch-sealed and labeled with REF: MOL1452 — reason: There is a potential for the direct amplification disc to malfunction  which may result in spillage of liquid from the disc.. Status: Ongoing — the recall is still being carried out.. Initiated 2023-06-14. Affected lots/codes: MOL1455 UDI-DI: 01-30816101025092  MOL1455 kit lot codes: P17044N  P17052N  P17301N  P17302N  P17303N  P17304N  P17305N  P17306N  P17351N  P17352N  P17353N  P17354N  P17614N  P17625N  P17650N  P17652N  P17653N  P17654N  P17687N  P17688N  P17731N   MOL1452 disc lot codes:  P15886N  P16794N  P16795N  P16796N  P16883N  P16885N  P17022N  P17056N  P17057N  P17047N  P17023N  P17176N  P17177N  P17294N  P17178N  P17295N  P17359N  P17362N  P17296N  P17361N  P17046N. A RECORDED FDA enforcement action (occurred=true).",
      "claimType": "official_fact",
      "reviewStatus": "current",
      "commercialInfluence": false,
      "epistemicStatus": {
        "occurred": true,
        "supported": true,
        "adjudged": true,
        "operative": true
      },
      "grounding": {
        "groundingType": "SourceCitation",
        "source": "openFDA drug & device enforcement (recall) reports — U.S. FDA",
        "sourceUrl": "https://www.accessdata.fda.gov/scripts/enforcement/enforce_rpt-Product-Tabs.cfm?action=select&recall_number=Z-2153-2023&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-2153-2023&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."
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      "name": "FDA classified recall Z-2153-2023 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",
        "adjudicator": {
          "name": "U.S. FDA recall classification (openFDA enforcement)",
          "url": "https://www.accessdata.fda.gov/scripts/enforcement/enforce_rpt-Product-Tabs.cfm?action=select&recall_number=Z-2153-2023&lang=eng"
        }
      },
      "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-2153-2023/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",
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      "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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            "Value": "Devices",
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          "item": {
            "Field": "Classification",
            "Value": "Class II",
            "Status": "determination"
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          "item": {
            "Field": "Status",
            "Value": "Ongoing — the recall is still being carried out.",
            "Status": "recorded"
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          "position": 5,
          "item": {
            "Field": "Recalling firm",
            "Value": "DiaSorin Molecular LLC",
            "Status": "recorded"
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          "position": 6,
          "item": {
            "Field": "Reason",
            "Value": "There is a potential for the direct amplification disc to malfunction  which may result in spillage of liquid from the disc.",
            "Status": "recorded"
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          "item": {
            "Field": "Initiated",
            "Value": "2023-06-14",
            "Status": "recorded"
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          "item": {
            "Field": "Lot/code info",
            "Value": "MOL1455 UDI-DI: 01-30816101025092  MOL1455 kit lot codes: P17044N  P17052N  P17301N  P17302N  P17303N  P17304N  P17305N  P17306N  P17351N  P17352N  P17353N  P17354N  P17614N  P17625N  P17650N  P17652N  P17653N  P17654N  P17687N  P17688N  P17731N   MOL1452 disc lot codes:  P15886N  P16794N  P16795N  P16796N  P16883N  P16885N  P17022N  P17056N  P17057N  P17047N  P17023N  P17176N  P17177N  P17294N  P17178N  P17295N  P17359N  P17362N  P17296N  P17361N  P17046N",
            "Status": "recorded"
          }
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          "item": {
            "Field": "Distribution pattern",
            "Value": "Worldwide - US Nationwide distribution including in the states of AL, AR, AZ, CA, CO, CT, DC, FL, GA, HI, IA, ID, IL, IN, KS, KY, LA, MA, MD, ME, MI, MN, MO, NC, ND, NE, NH,   NJ, NM, NV, NY, OH, OK, PA, RI, SD, TN, TX, VA, VT, WA, WI, WV and the countries of Bangladesh, Canada, Israel, Italy.",
            "Status": "recorded"
          }
        }
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