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  "@id": "https://drug-device-safety-atlas.ryanjhunter.workers.dev/recalls/Z-1387-2025.jsonld",
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  "name": "DxI 9000 Access Immunoassay Analyzer, Catalog Number C11137, with Component PCB, TSI/RSI firmware C29278",
  "description": "FDA recall Z-1387-2025 — Beckman Coulter, Inc. is recalling DxI 9000 Access Immunoassay Analyzer, Catalog Number C11137, with Component PCB, TSI/RSI firmware C29278 (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": "DxI 9000 Access Immunoassay Analyzer, Catalog Number C11137, with Component PCB, TSI/RSI firmware C29278",
    "manufacturer": {
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      "name": "Beckman Coulter, Inc."
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      "name": "FDA recall Z-1387-2025: Beckman Coulter, Inc. is recalling DxI 9000 Access Immunoassay Analyzer, Catalog Number C11137, with Component PCB, TSI/RSI firmware C29278",
      "text": "The FDA logged enforcement record Z-1387-2025: Beckman Coulter, Inc. is voluntarily recalling DxI 9000 Access Immunoassay Analyzer, Catalog Number C11137, with Component PCB, TSI/RSI firmware C29278 — reason: Beckman Coulter identified that an issue for DxI 9000 tip stocker interface (TSI) and reagent storage interface (RSI) boards with the firmware version 1.1.0.0 can cause sub-system communication failures. This failure could result in a delay in reporting patient results.. Status: Ongoing — the recall is still being carried out.. Initiated 2025-02-06. Affected lots/codes: UDI-DI: 15099590732103; Serial Numbers: 300158 300161 300164 300167 300169 300175 300178 300179 300182 300183 300185 300189 300194 300197 300201 300202 300204 300210 300216 300217 300218 300220 300224 300225 300233 300234 300236 300237 300239 300240 300241 300243 300244 300246 300247 300252 300255 300256 300260 300267 300270 300272 300273 300275 300280 300288 300290 300295 300296 300299 300300 300304 300313 300314 300317 300318 300321 300322 300323 300324 300333 300334 300336 300338 300339 300341 300351 300362 300364 300368 300370 300373 300374 300375 300379 300380 300385 300386 300388 300389. A RECORDED FDA enforcement action (occurred=true).",
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        "sourceUrl": "https://www.accessdata.fda.gov/scripts/enforcement/enforce_rpt-Product-Tabs.cfm?action=select&recall_number=Z-1387-2025&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-1387-2025&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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      "@id": "https://drug-device-safety-atlas.ryanjhunter.workers.dev/recalls/Z-1387-2025/fda-classification",
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      "name": "FDA classified recall Z-1387-2025 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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      "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-1387-2025/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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        "adjudicator": null
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      "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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            "Field": "Recalling firm",
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            "Field": "Reason",
            "Value": "Beckman Coulter identified that an issue for DxI 9000 tip stocker interface (TSI) and reagent storage interface (RSI) boards with the firmware version 1.1.0.0 can cause sub-system communication failures. This failure could result in a delay in reporting patient results.",
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            "Field": "Distribution pattern",
            "Value": "Worldwide - US Nationwide distribution in the states of FL, TX, WA.",
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