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  "name": "Sysmex PS-10 Sample Preparation System with software version 1.5 and 1.6., Catalog Number BQ716341.  Product usage for automated pipetting, diluting, and specimen processing workstations for flow cytometric analysis.",
  "description": "FDA recall Z-1113-2025 — Sysmex America, Inc. is recalling Sysmex PS-10 Sample Preparation System with software version 1.5 and 1.6., Catalog Number BQ716341.  Product usage for automated pipetting, diluting, and specimen processing workstations for flow cytometric analysis. (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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    "@type": "schema:MedicalDevice",
    "name": "Sysmex PS-10 Sample Preparation System with software version 1.5 and 1.6., Catalog Number BQ716341.  Product usage for automated pipetting, diluting, and specimen processing workstations for flow cytometric analysis.",
    "manufacturer": {
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      "name": "Sysmex America, Inc."
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      "@id": "https://drug-device-safety-atlas.ryanjhunter.workers.dev/recalls/Z-1113-2025/enforcement-record",
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      "name": "FDA recall Z-1113-2025: Sysmex America, Inc. is recalling Sysmex PS-10 Sample Preparation System with software version 1.5 and 1.6., Catalog Number BQ716341.  Product usage for automated pipetting, diluting, and specimen processing workstations for flow cytometric analysis.",
      "text": "The FDA logged enforcement record Z-1113-2025: Sysmex America, Inc. is voluntarily recalling Sysmex PS-10 Sample Preparation System with software version 1.5 and 1.6., Catalog Number BQ716341.  Product usage for automated pipetting, diluting, and specimen processing workstations for flow cytometric analysis. — reason: Sysmex was made aware of a report of false results due to carry-over caused by the sporadic omission of the probe wash step during antibody pipetting on the PS-10 Sample Preparation System.. Status: Ongoing — the recall is still being carried out.. Initiated 2025-01-06. Affected lots/codes: UDI-DI: 04987562501908; Serial Numbers: 1908002275 1908002276 1908009775 1910009588 1910011295 1912002638 2103013913 2108004629 2108004630 2108004631 2108004632 2112005423 2112005425 2203014206 2203014207 2203014208 2205012732 2205012734 2206005973 2206012294 2208015835 2210003722 2210003723 2210003724 2212010048 1903011966 1903011968 1910009589 1912002640 2103013912 2208015834 1903011967. A RECORDED FDA enforcement action (occurred=true).",
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      "reviewStatus": "current",
      "commercialInfluence": false,
      "epistemicStatus": {
        "occurred": true,
        "supported": true,
        "adjudged": true,
        "operative": true
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        "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-1113-2025&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-1113-2025&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-1113-2025/fda-classification",
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      "name": "FDA classified recall Z-1113-2025 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."
    },
    {
      "@id": "https://drug-device-safety-atlas.ryanjhunter.workers.dev/recalls/Z-1113-2025/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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        "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.",
            "Status": "recorded"
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            "Field": "Recalling firm",
            "Value": "Sysmex America, Inc.",
            "Status": "recorded"
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            "Value": "Sysmex was made aware of a report of false results due to carry-over caused by the sporadic omission of the probe wash step during antibody pipetting on the PS-10 Sample Preparation System.",
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            "Value": "UDI-DI: 04987562501908; Serial Numbers: 1908002275 1908002276 1908009775 1910009588 1910011295 1912002638 2103013913 2108004629 2108004630 2108004631 2108004632 2112005423 2112005425 2203014206 2203014207 2203014208 2205012732 2205012734 2206005973 2206012294 2208015835 2210003722 2210003723 2210003724 2212010048 1903011966 1903011968 1910009589 1912002640 2103013912 2208015834 1903011967",
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          "item": {
            "Field": "Distribution pattern",
            "Value": "US Nationwide.",
            "Status": "recorded"
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