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  "@id": "https://drug-device-safety-atlas.ryanjhunter.workers.dev/recalls/Z-1185-2026.jsonld",
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  "name": "Conductivity Standard Solution  Catalog/Model Numbers:  10001, 10011, 10021, 10032, 10040, 10040c, and 10041    Conductivity Standard Solutions are a secondary standard solution used for the  calibration of conductivity cells together with conductivity meters",
  "description": "FDA recall Z-1185-2026 — NIPRO Technical Services, Inc. is recalling Conductivity Standard Solution  Catalog/Model Numbers:  10001, 10011, 10021, 10032, 10040, 10040c, and 10041    Conductivity Standard Solutions are a secondary standard solution used for the  calibration of conductivity cells together with conductivity meters (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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      "name": "U.S. Food & Drug Administration"
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  "sameAs": "https://www.accessdata.fda.gov/scripts/enforcement/enforce_rpt-Product-Tabs.cfm?action=select&recall_number=Z-1185-2026&lang=eng",
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    "@type": "schema:MedicalDevice",
    "name": "Conductivity Standard Solution  Catalog/Model Numbers:  10001, 10011, 10021, 10032, 10040, 10040c, and 10041    Conductivity Standard Solutions are a secondary standard solution used for the  calibration of conductivity cells together with conductivity meters",
    "manufacturer": {
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      "name": "NIPRO Technical Services, Inc."
    }
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      "@id": "https://drug-device-safety-atlas.ryanjhunter.workers.dev/recalls/Z-1185-2026/enforcement-record",
      "@type": "schema:Claim",
      "name": "FDA recall Z-1185-2026: NIPRO Technical Services, Inc. is recalling Conductivity Standard Solution  Catalog/Model Numbers:  10001, 10011, 10021, 10032, 10040, 10040c, and 10041    Conductivity Standard Solutions are a secondary standard solution used for the  calibration of conductivity cells together with conductivity meters",
      "text": "The FDA logged enforcement record Z-1185-2026: NIPRO Technical Services, Inc. is voluntarily recalling Conductivity Standard Solution  Catalog/Model Numbers:  10001, 10011, 10021, 10032, 10040, 10040c, and 10041    Conductivity Standard Solutions are a secondary standard solution used for the  calibration of conductivity cells together with conductivity meters — reason: due to a defect associated with the conductivity values of the solution used to calibrate meters and result in the reporting of incorrect conductivity values for dialysate.. Status: Ongoing — the recall is still being carried out.. Initiated 2025-12-12. Affected lots/codes: Catalog/Model Numbers/ Lot Numbers / UDI codes: 10001 14250616-1019106  (01) 0 0850016 97600 0 (17) 251030 (10) SHOWCASE 10011 14250616-1019107  (01) 0 0850016 97609 3 (17) 251030 (10) SHOWCASE 10040c 50250624-1019120  (01) 0 0850016 97636 9 (17) 251030 (10) SHOWCASE 10040 50250624-1019119  (01) 0 0850016 97635 2 (17) 251030 (10) SHOWCASE 10032 14250616-1019108  (01) 0 0850016 97631 1 (17) 251030 (10) SHOWCASE 10041 50250522-1018643  (01) 0 0850016 97637 6 (17) 251030 (10) SHOWCASE 10041 50250624-1019121  (01) 0 0850016 97637 6 (17) 251030 (10) SHOWCASE 10021 15F250603-1018834  (01) 0 0850016 97619 2 (17) 251030 (10) SHOWCASE. A RECORDED FDA enforcement action (occurred=true).",
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      "epistemicStatus": {
        "occurred": true,
        "supported": true,
        "adjudged": true,
        "operative": true
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      "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-1185-2026&lang=eng",
        "value": "Devices recall, status Ongoing",
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          "url": "https://www.accessdata.fda.gov/scripts/enforcement/enforce_rpt-Product-Tabs.cfm?action=select&recall_number=Z-1185-2026&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-1185-2026 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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        "value": "Class II",
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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."
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    {
      "@id": "https://drug-device-safety-atlas.ryanjhunter.workers.dev/recalls/Z-1185-2026/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.",
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      "reviewStatus": "current",
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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": "Class II",
            "Status": "determination"
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            "Field": "Status",
            "Value": "Ongoing — the recall is still being carried out.",
            "Status": "recorded"
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            "Field": "Recalling firm",
            "Value": "NIPRO Technical Services, Inc.",
            "Status": "recorded"
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          "position": 6,
          "item": {
            "Field": "Reason",
            "Value": "due to a defect associated with the conductivity values of the solution used to calibrate meters and result in the reporting of incorrect conductivity values for dialysate.",
            "Status": "recorded"
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            "Field": "Initiated",
            "Value": "2025-12-12",
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            "Field": "Lot/code info",
            "Value": "Catalog/Model Numbers/ Lot Numbers / UDI codes: 10001 14250616-1019106  (01) 0 0850016 97600 0 (17) 251030 (10) SHOWCASE 10011 14250616-1019107  (01) 0 0850016 97609 3 (17) 251030 (10) SHOWCASE 10040c 50250624-1019120  (01) 0 0850016 97636 9 (17) 251030 (10) SHOWCASE 10040 50250624-1019119  (01) 0 0850016 97635 2 (17) 251030 (10) SHOWCASE 10032 14250616-1019108  (01) 0 0850016 97631 1 (17) 251030 (10) SHOWCASE 10041 50250522-1018643  (01) 0 0850016 97637 6 (17) 251030 (10) SHOWCASE 10041 50250624-1019121  (01) 0 0850016 97637 6 (17) 251030 (10) SHOWCASE 10021 15F250603-1018834  (01) 0 0850016 97619 2 (17) 251030 (10) SHOWCASE",
            "Status": "recorded"
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          "item": {
            "Field": "Distribution pattern",
            "Value": "U.S. Nationwide distribution in the states of AL, AR, AZ, CA, DE, FL, GA. IL, IN, KS, MI, MO, NC, ND, NJ, NV, NY, OH, OK, OR, PA, SC, TN TX, UT, VA, and WA.",
            "Status": "recorded"
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