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  "@id": "https://drug-device-safety-atlas.ryanjhunter.workers.dev/recalls/Z-0105-2024.jsonld",
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  "name": "Multichem IA Plus, Part Codes:  a) 08P86-10, b) 08P86-19",
  "description": "FDA recall Z-0105-2024 — TECHNO-PATH MANUFACTURING LTD. is recalling Multichem IA Plus, Part Codes:  a) 08P86-10, b) 08P86-19 (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": "Multichem IA Plus, Part Codes:  a) 08P86-10, b) 08P86-19",
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      "@id": "https://drug-device-safety-atlas.ryanjhunter.workers.dev/recalls/Z-0105-2024/enforcement-record",
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      "name": "FDA recall Z-0105-2024: TECHNO-PATH MANUFACTURING LTD. is recalling Multichem IA Plus, Part Codes:  a) 08P86-10, b) 08P86-19",
      "text": "The FDA logged enforcement record Z-0105-2024: TECHNO-PATH MANUFACTURING LTD. is voluntarily recalling Multichem IA Plus, Part Codes:  a) 08P86-10, b) 08P86-19 — reason: Technopath Manufacturing Ltd. has identified an issue with the glass vial commodity used to fill the Multichem S Plus Level 1, Multichem S Plus Level 2, Multichem S Plus Level 3, Multichem IA Plus and Multichem P Controls. Some customers have experienced broken vials when receiving or thawing Technopath Multichem IA Plus and Multichem S Plus Controls. Breakages have been observed upon delivery, while thawing or while opening the vial. The breakages can result in the bottom of the vial breaking off, breakage in the neck thread area or cracking on the sides of the vial. This may expose the user to biohazardous material if cut and may cause a delay in patient results.. Status: Ongoing — the recall is still being carried out.. Initiated 2023-08-25. Affected lots/codes: a) 08P86-10, UDI/DI 05391523440745, Lot Numbers:  32004230, 35106210, 35810210, 36404220, 37209220;  b) 08P86-19, UDI/DI 05391523441636, Lot Numbers:  35506210, 36010210, 36604220, 37409220. A RECORDED FDA enforcement action (occurred=true).",
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        "supported": true,
        "adjudged": true,
        "operative": true
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        "sourceUrl": "https://www.accessdata.fda.gov/scripts/enforcement/enforce_rpt-Product-Tabs.cfm?action=select&recall_number=Z-0105-2024&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-0105-2024&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."
    },
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      "@id": "https://drug-device-safety-atlas.ryanjhunter.workers.dev/recalls/Z-0105-2024/fda-classification",
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      "name": "FDA classified recall Z-0105-2024 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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        }
      },
      "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-0105-2024/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.",
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      "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": "TECHNO-PATH MANUFACTURING LTD.",
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          "item": {
            "Field": "Reason",
            "Value": "Technopath Manufacturing Ltd. has identified an issue with the glass vial commodity used to fill the Multichem S Plus Level 1, Multichem S Plus Level 2, Multichem S Plus Level 3, Multichem IA Plus and Multichem P Controls. Some customers have experienced broken vials when receiving or thawing Technopath Multichem IA Plus and Multichem S Plus Controls. Breakages have been observed upon delivery, while thawing or while opening the vial. The breakages can result in the bottom of the vial breaking off, breakage in the neck thread area or cracking on the sides of the vial. This may expose the user to biohazardous material if cut and may cause a delay in patient results.",
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            "Value": "a) 08P86-10, UDI/DI 05391523440745, Lot Numbers:  32004230, 35106210, 35810210, 36404220, 37209220;  b) 08P86-19, UDI/DI 05391523441636, Lot Numbers:  35506210, 36010210, 36604220, 37409220",
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          "item": {
            "Field": "Distribution pattern",
            "Value": "US Nationwide distribution in the state of Illinois.",
            "Status": "recorded"
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