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  "@id": "https://drug-device-safety-atlas.ryanjhunter.workers.dev/recalls/Z-1586-2026.jsonld",
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  "name": "Brand Name: Aptima HPV Assay  Product Name: Aptima HPV Assay  Model/Catalog Number: 303585  Product Description: Aptima HPV assay  Component: No",
  "description": "FDA recall Z-1586-2026 — Hologic, Inc. is recalling Brand Name: Aptima HPV Assay  Product Name: Aptima HPV Assay  Model/Catalog Number: 303585  Product Description: Aptima HPV assay  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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  "dateModified": "2026-06-24T07:02:03.626072+00:00",
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      "name": "FDA recall Z-1586-2026: Hologic, Inc. is recalling Brand Name: Aptima HPV Assay  Product Name: Aptima HPV Assay  Model/Catalog Number: 303585  Product Description: Aptima HPV assay  Component: No",
      "text": "The FDA logged enforcement record Z-1586-2026: Hologic, Inc. is voluntarily recalling Brand Name: Aptima HPV Assay  Product Name: Aptima HPV Assay  Model/Catalog Number: 303585  Product Description: Aptima HPV assay  Component: No — reason: Due to product exhibiting potential to generate either invalid or false negative results.. Status: Ongoing — the recall is still being carried out.. Initiated 2026-02-18. Affected lots/codes: Lot Code: The Aptima HPV Assay Kit Part Number 303585, Master Lot 929785 contains one Refrigerated Box (PN 302883) and one Room Temperature Box (PN 302885). The following are the UDI number for each box:  UDI Number for PN 302883: 15420045500051 UDI Number for PN 302885: 15420045500068. A RECORDED FDA enforcement action (occurred=true).",
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        "value": "Devices recall, status Ongoing",
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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RECORD of measured/reported events (occurred=true) from openFDA drug & device enforcement (recall) reports — U.S. FDA; superseded when openFDA drug & device enforcement (recall) reports — U.S. FDA publishes its next release."
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      "@id": "https://drug-device-safety-atlas.ryanjhunter.workers.dev/recalls/Z-1586-2026/fda-classification",
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      "name": "FDA classified recall Z-1586-2026 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."
    },
    {
      "@id": "https://drug-device-safety-atlas.ryanjhunter.workers.dev/recalls/Z-1586-2026/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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        "source": "Atlas Commons L5 boundary (enforcement-action ≠ harm causation)",
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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": "Ongoing — the recall is still being carried out.",
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            "Status": "recorded"
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            "Status": "recorded"
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            "Field": "Initiated",
            "Value": "2026-02-18",
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            "Field": "Lot/code info",
            "Value": "Lot Code: The Aptima HPV Assay Kit Part Number 303585, Master Lot 929785 contains one Refrigerated Box (PN 302883) and one Room Temperature Box (PN 302885). The following are the UDI number for each box:  UDI Number for PN 302883: 15420045500051 UDI Number for PN 302885: 15420045500068",
            "Status": "recorded"
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          "item": {
            "Field": "Distribution pattern",
            "Value": "U.S. Nationwide distribution in the states of CA, FL. IA, IL, MO, NC, NM, PR, and TN.",
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