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  "name": "FreeStyle Libre 3 App, part of Continuous Glucose Monitoring System, when used on the Android 13 Operating System",
  "description": "FDA recall Z-0734-2024 — Abbott Diabetes Care, Inc. is recalling FreeStyle Libre 3 App, part of Continuous Glucose Monitoring System, when used on the Android 13 Operating System (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": "FreeStyle Libre 3 App, part of Continuous Glucose Monitoring System, when used on the Android 13 Operating System",
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      "name": "FDA recall Z-0734-2024: Abbott Diabetes Care, Inc. is recalling FreeStyle Libre 3 App, part of Continuous Glucose Monitoring System, when used on the Android 13 Operating System",
      "text": "The FDA logged enforcement record Z-0734-2024: Abbott Diabetes Care, Inc. is voluntarily recalling FreeStyle Libre 3 App, part of Continuous Glucose Monitoring System, when used on the Android 13 Operating System — reason: If using affected glucose monitoring app on Android 13 Operating System, extended periods of signal loss may be experienced, due to app not connected, which could impact ability to receive glucose reading/alarms, which could lead to undetected low or high glucose, which could result in delayed treatment: not taking insulin (for high glucose), or not taking glucose (for low glucose) when required.. Status: Completed — the FDA has determined all recalling-firm actions are complete (the FDA's review may still be open).. Initiated 2023-02-09. Affected lots/codes: UDI-DI: 00357599816001, Software v.3.4.0 and below. A RECORDED FDA enforcement action (occurred=true).",
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        "value": "Devices recall, status Completed",
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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RECORD of measured/reported events (occurred=true) from openFDA drug & device enforcement (recall) reports — U.S. FDA; superseded when openFDA drug & device enforcement (recall) reports — U.S. FDA publishes its next release."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-0734-2024/fda-classification",
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      "name": "FDA classified recall Z-0734-2024 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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      "@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",
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      "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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            "Field": "Reason",
            "Value": "If using affected glucose monitoring app on Android 13 Operating System, extended periods of signal loss may be experienced, due to app not connected, which could impact ability to receive glucose reading/alarms, which could lead to undetected low or high glucose, which could result in delayed treatment: not taking insulin (for high glucose), or not taking glucose (for low glucose) when required.",
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          "item": {
            "Field": "Distribution pattern",
            "Value": "US Nationwide distribution in the states of NY, CA, NJ, UT, PA, MS, OH, TX, MN, FL, LA, NE, MI, VA, NC, MA, IN, SC, IA.",
            "Status": "recorded"
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