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  "@id": "https://drug-device-safety-atlas.ryanjhunter.workers.dev/recalls/Z-1136-2026.jsonld",
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  "name": "TS-10/TS-10H Tube Sorter, automatic sorting system for sorting barcoded sample tubes, Catalog Number BN168792, running software versions 00-17",
  "description": "FDA recall Z-1136-2026 — Sysmex America, Inc. is recalling TS-10/TS-10H Tube Sorter, automatic sorting system for sorting barcoded sample tubes, Catalog Number BN168792, running software versions 00-17 (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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  "sameAs": "https://www.accessdata.fda.gov/scripts/enforcement/enforce_rpt-Product-Tabs.cfm?action=select&recall_number=Z-1136-2026&lang=eng",
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    "name": "TS-10/TS-10H Tube Sorter, automatic sorting system for sorting barcoded sample tubes, Catalog Number BN168792, running software versions 00-17",
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      "name": "Sysmex America, Inc."
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      "@id": "https://drug-device-safety-atlas.ryanjhunter.workers.dev/recalls/Z-1136-2026/enforcement-record",
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      "name": "FDA recall Z-1136-2026: Sysmex America, Inc. is recalling TS-10/TS-10H Tube Sorter, automatic sorting system for sorting barcoded sample tubes, Catalog Number BN168792, running software versions 00-17",
      "text": "The FDA logged enforcement record Z-1136-2026: Sysmex America, Inc. is voluntarily recalling TS-10/TS-10H Tube Sorter, automatic sorting system for sorting barcoded sample tubes, Catalog Number BN168792, running software versions 00-17 — reason: Under specific conditions, the lift's electromagnetic holding force may disengage unexpectedly, allowing unintended downward movement of the lift.. Status: Ongoing — the recall is still being carried out.. Initiated 2025-12-15. Affected lots/codes: Serial Numbers: 11281 11611 11918 11790 12040 11991 12218 11950 11795 11533 11635 12054 11610 11453 11753 11539 11990 12298 11774 11541 11981 11788 11834 12005 11907 11524 12237 11246 12154 12104 12299 12176 11711 11420 12153 12177 12074 11405 11303 12039 11250 11336 12137 12075. 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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        "sourceUrl": "https://www.accessdata.fda.gov/scripts/enforcement/enforce_rpt-Product-Tabs.cfm?action=select&recall_number=Z-1136-2026&lang=eng",
        "value": "Devices recall, status Ongoing",
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          "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-1136-2026&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."
    },
    {
      "@id": "https://drug-device-safety-atlas.ryanjhunter.workers.dev/recalls/Z-1136-2026/fda-classification",
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      "name": "FDA classified recall Z-1136-2026 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-1136-2026/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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            "Status": "recorded"
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            "Value": "Under specific conditions, the lift's electromagnetic holding force may disengage unexpectedly, allowing unintended downward movement of the lift.",
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            "Value": "Serial Numbers: 11281 11611 11918 11790 12040 11991 12218 11950 11795 11533 11635 12054 11610 11453 11753 11539 11990 12298 11774 11541 11981 11788 11834 12005 11907 11524 12237 11246 12154 12104 12299 12176 11711 11420 12153 12177 12074 11405 11303 12039 11250 11336 12137 12075",
            "Status": "recorded"
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          "item": {
            "Field": "Distribution pattern",
            "Value": "US Nationwide.",
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