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  "name": "Cue Health COVID-19 Test Cartridge  REF 2900005    Cue COVID-19 Test  Cue COVID-19 Test for Home and Over The Counter (OTC)",
  "description": "FDA recall Z-0091-2025 — CUE HEALTH INC is recalling Cue Health COVID-19 Test Cartridge  REF 2900005    Cue COVID-19 Test  Cue COVID-19 Test for Home and Over The Counter (OTC) (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": "Cue Health COVID-19 Test Cartridge  REF 2900005    Cue COVID-19 Test  Cue COVID-19 Test for Home and Over The Counter (OTC)",
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      "name": "FDA recall Z-0091-2025: CUE HEALTH INC is recalling Cue Health COVID-19 Test Cartridge  REF 2900005    Cue COVID-19 Test  Cue COVID-19 Test for Home and Over The Counter (OTC)",
      "text": "The FDA logged enforcement record Z-0091-2025: CUE HEALTH INC is voluntarily recalling Cue Health COVID-19 Test Cartridge  REF 2900005    Cue COVID-19 Test  Cue COVID-19 Test for Home and Over The Counter (OTC) — reason: Due to modified test kits being marketed and distributed without FDA Approval, Clearance or Authorization.. Status: Ongoing — the recall is still being carried out.. Initiated 2024-05-24. Affected lots/codes: Product code: 2900005 UDI code: N/A Lot Numbers: 30757C 30761G 30760C 30884G 30885G 30762G 30886G 30879C 30882C 30918C 30889G 30926G 30923C 31032G 30924C 31040C 31041C 31033G 31042C 31043C 31044C 31036G 31045C 31046C 31037G 31158C 31162C 31161C 31165B 31163E 31166B 31038B 31374B 31373E 31400B 31465E 31464B 31403B 31408E 31404B 31476B 31410E 31477B 31478B 31540B 31541B 31542B 31543B 31544B 31545B 31546B 31479B 31480B 31537L 31739L. A RECORDED FDA enforcement action (occurred=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-0091-2025&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-0091-2025&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-0091-2025/fda-classification",
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      "name": "FDA classified recall Z-0091-2025 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-0091-2025/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.",
      "claimType": "interpretation",
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        "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.",
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            "Value": "Due to modified test kits being marketed and distributed without FDA Approval, Clearance or Authorization.",
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            "Field": "Initiated",
            "Value": "2024-05-24",
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