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  "name": "Owner's Booklets and Instructions for Use that are used with the following blood glucose measuring devices.   Description/Item:  Walgreens TRUE METRIX Kit/RE4001-01,  Leader TRUE METRIX Kit/RE4002-01,  Leader TRUE METRIX Meter Only/RE4002-40,  CVS TRUE METRIX Kit/RE4007-01SB,  GNP TRUE METRIX Meter Only/RE4011-00,  GNP TRUE METRIX Kit\t/RE4011-01,  MEIJER TRUE METRIX Kit/RE4019-01,  FRED'S TRUE METRIX Kit/RE4023-01,  DISCOUNT DRUG TRUE METRIX Kit/RE4025-01,  KINRAY TRUE METRIX Kit/RE4027-01,  HEB TRUE METRIX Kit/RE4031-01,  McKesson TRUE METRIX Starter Kit/RE4051-43,  SUNMARK TRUE METRIX Meter Only/RE4054-00,  SUNMARK TRUE METRIX Kit/RE4054-01,  Signature Care TRUE METRIX Kit/RE4060-01,  CareOne TRUE METRIX Kit/RE4061-01,  RITE AID TRUE METRIX Kit/RE4066-01,  Liberty TRUE METRIX Meter Only/RE4078-40,  HUMANA TRUE METRIX Starter Kit/RE4081-03,  Wegmans TRUE METRIX Kit/RE4087-01,  HEALTHMART TRUE METRIX Meter Only/RE4089-00,  HEALTHMART TRUE METRIX Kit/RE4089-01,  ARRIVA TRUE METRIX Meter Only/RE4095-40,  HealthyAccents TRUE METRIX Kit/RE4097-01,  Shopko TRUE METRIX Kit/RE4098-01,  Henry Schein TRUE METRIX Kit/RE4099-40,  Henry Schein TRUE METRIX Meter Only/RE4099-45,  Millennium Pharmay Services TRUE METRIX Kit/RE4202-43,  Kroger TRUE METRIX  Kit/RE4203-01,  TOPCARE TRUE METRIX Kit/RE4209-01,  Foster and Thrive TRUE METRIX Kit/RE4211-01,  TRUE METRIX Meter Only/RE4H01-00,  TRUE METRIX Kit/RE4H01-01,  TRUE METRIX Starter Kit/RE4H01-04,  TRUE METRIX NFRS Meter Only/RE4H01-40,  TRUE METRIX NFRS Starter Kit/RE4H01-43,  TRUE METRIX Kit/RE4H01-51,  TRUE METRIX Meter Only (mg/dL)/RE4i01-00,  TRUE METRIX Kit (mg/dL)/RE4i01-01,  TRUE METRIX Kit (mg/dL)/RE4i01-02,  TRUE METRIX Starter Kit (mg/dL)/RE4i03-02,  TRUE METRIX Kit (mmol/L)/RE4i03-11,  Farmacia Benavides TRUE METRIX Meter Only (Mexico - mg/dL)/RE4i05-00,  Farmacia del Ahorro TRUE METRIX Meter Only (Mexico - mg/dL)/RE4i07-00,  TRUE METRIX Meter Only (Mexico - mg/dL)/RE4i23-00,  TRUE METRIX Meter Only (Jamaica - mmol/L)/RE4i29-11,  TRUE METRIX Kit (mg/dL)/RE4i61-02,  TRUE METRIX Kit (mg/dL)/RE4i61-02THI,  TRUE METRIX Kit (United Kingdom - mmol/L)/RE4i82-11,  TRUE METRIX Starter Kit (United Kingdom - mmol/L)/RE4i82-12.",
  "description": "FDA recall Z-1545-2026 — Trividia Health, Inc. is recalling Owner's Booklets and Instructions for Use that are used with the following blood glucose measuring devices.   Description/Item:  Walgreens TRUE METRIX Kit/RE4001-01,  Leader TRUE METRIX Kit/RE4002-01,  Leader TRUE METRIX Meter Only/RE4002-40,  CVS TRUE METRIX Kit/RE4007-01SB,  GNP TRUE METRIX Meter Only/RE4011-00,  GNP TRUE METRIX Kit\t/RE4011-01,  MEIJER TRUE METRIX Kit/RE4019-01,  FRED'S TRUE METRIX Kit/RE4023-01,  DISCOUNT DRUG TRUE METRIX Kit/RE4025-01,  KINRAY TRUE METRIX Kit/RE4027-01,  HEB TRUE METRIX Kit/RE4031-01,  McKesson TRUE METRIX Starter Kit/RE4051-43,  SUNMARK TRUE METRIX Meter Only/RE4054-00,  SUNMARK TRUE METRIX Kit/RE4054-01,  Signature Care TRUE METRIX Kit/RE4060-01,  CareOne TRUE METRIX Kit/RE4061-01,  RITE AID TRUE METRIX Kit/RE4066-01,  Liberty TRUE METRIX Meter Only/RE4078-40,  HUMANA TRUE METRIX Starter Kit/RE4081-03,  Wegmans TRUE METRIX Kit/RE4087-01,  HEALTHMART TRUE METRIX Meter Only/RE4089-00,  HEALTHMART TRUE METRIX Kit/RE4089-01,  ARRIVA TRUE METRIX Meter Only/RE4095-40,  HealthyAccents TRUE METRIX Kit/RE4097-01,  Shopko TRUE METRIX Kit/RE4098-01,  Henry Schein TRUE METRIX Kit/RE4099-40,  Henry Schein TRUE METRIX Meter Only/RE4099-45,  Millennium Pharmay Services TRUE METRIX Kit/RE4202-43,  Kroger TRUE METRIX  Kit/RE4203-01,  TOPCARE TRUE METRIX Kit/RE4209-01,  Foster and Thrive TRUE METRIX Kit/RE4211-01,  TRUE METRIX Meter Only/RE4H01-00,  TRUE METRIX Kit/RE4H01-01,  TRUE METRIX Starter Kit/RE4H01-04,  TRUE METRIX NFRS Meter Only/RE4H01-40,  TRUE METRIX NFRS Starter Kit/RE4H01-43,  TRUE METRIX Kit/RE4H01-51,  TRUE METRIX Meter Only (mg/dL)/RE4i01-00,  TRUE METRIX Kit (mg/dL)/RE4i01-01,  TRUE METRIX Kit (mg/dL)/RE4i01-02,  TRUE METRIX Starter Kit (mg/dL)/RE4i03-02,  TRUE METRIX Kit (mmol/L)/RE4i03-11,  Farmacia Benavides TRUE METRIX Meter Only (Mexico - mg/dL)/RE4i05-00,  Farmacia del Ahorro TRUE METRIX Meter Only (Mexico - mg/dL)/RE4i07-00,  TRUE METRIX Meter Only (Mexico - mg/dL)/RE4i23-00,  TRUE METRIX Meter Only (Jamaica - mmol/L)/RE4i29-11,  TRUE METRIX Kit (mg/dL)/RE4i61-02,  TRUE METRIX Kit (mg/dL)/RE4i61-02THI,  TRUE METRIX Kit (United Kingdom - mmol/L)/RE4i82-11,  TRUE METRIX Starter Kit (United Kingdom - mmol/L)/RE4i82-12. (Devices, Class I). 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": "Owner's Booklets and Instructions for Use that are used with the following blood glucose measuring devices.   Description/Item:  Walgreens TRUE METRIX Kit/RE4001-01,  Leader TRUE METRIX Kit/RE4002-01,  Leader TRUE METRIX Meter Only/RE4002-40,  CVS TRUE METRIX Kit/RE4007-01SB,  GNP TRUE METRIX Meter Only/RE4011-00,  GNP TRUE METRIX Kit\t/RE4011-01,  MEIJER TRUE METRIX Kit/RE4019-01,  FRED'S TRUE METRIX Kit/RE4023-01,  DISCOUNT DRUG TRUE METRIX Kit/RE4025-01,  KINRAY TRUE METRIX Kit/RE4027-01,  HEB TRUE METRIX Kit/RE4031-01,  McKesson TRUE METRIX Starter Kit/RE4051-43,  SUNMARK TRUE METRIX Meter Only/RE4054-00,  SUNMARK TRUE METRIX Kit/RE4054-01,  Signature Care TRUE METRIX Kit/RE4060-01,  CareOne TRUE METRIX Kit/RE4061-01,  RITE AID TRUE METRIX Kit/RE4066-01,  Liberty TRUE METRIX Meter Only/RE4078-40,  HUMANA TRUE METRIX Starter Kit/RE4081-03,  Wegmans TRUE METRIX Kit/RE4087-01,  HEALTHMART TRUE METRIX Meter Only/RE4089-00,  HEALTHMART TRUE METRIX Kit/RE4089-01,  ARRIVA TRUE METRIX Meter Only/RE4095-40,  HealthyAccents TRUE METRIX Kit/RE4097-01,  Shopko TRUE METRIX Kit/RE4098-01,  Henry Schein TRUE METRIX Kit/RE4099-40,  Henry Schein TRUE METRIX Meter Only/RE4099-45,  Millennium Pharmay Services TRUE METRIX Kit/RE4202-43,  Kroger TRUE METRIX  Kit/RE4203-01,  TOPCARE TRUE METRIX Kit/RE4209-01,  Foster and Thrive TRUE METRIX Kit/RE4211-01,  TRUE METRIX Meter Only/RE4H01-00,  TRUE METRIX Kit/RE4H01-01,  TRUE METRIX Starter Kit/RE4H01-04,  TRUE METRIX NFRS Meter Only/RE4H01-40,  TRUE METRIX NFRS Starter Kit/RE4H01-43,  TRUE METRIX Kit/RE4H01-51,  TRUE METRIX Meter Only (mg/dL)/RE4i01-00,  TRUE METRIX Kit (mg/dL)/RE4i01-01,  TRUE METRIX Kit (mg/dL)/RE4i01-02,  TRUE METRIX Starter Kit (mg/dL)/RE4i03-02,  TRUE METRIX Kit (mmol/L)/RE4i03-11,  Farmacia Benavides TRUE METRIX Meter Only (Mexico - mg/dL)/RE4i05-00,  Farmacia del Ahorro TRUE METRIX Meter Only (Mexico - mg/dL)/RE4i07-00,  TRUE METRIX Meter Only (Mexico - mg/dL)/RE4i23-00,  TRUE METRIX Meter Only (Jamaica - mmol/L)/RE4i29-11,  TRUE METRIX Kit (mg/dL)/RE4i61-02,  TRUE METRIX Kit (mg/dL)/RE4i61-02THI,  TRUE METRIX Kit (United Kingdom - mmol/L)/RE4i82-11,  TRUE METRIX Starter Kit (United Kingdom - mmol/L)/RE4i82-12.",
    "manufacturer": {
      "@type": "schema:Organization",
      "name": "Trividia Health, Inc."
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  "claims": [
    {
      "@id": "https://drug-device-safety-atlas.ryanjhunter.workers.dev/recalls/Z-1545-2026/enforcement-record",
      "@type": "schema:Claim",
      "name": "FDA recall Z-1545-2026: Trividia Health, Inc. is recalling Owner's Booklets and Instructions for Use that are used with the following blood glucose measuring devices.   Description/Item:  Walgreens TRUE METRIX Kit/RE4001-01,  Leader TRUE METRIX Kit/RE4002-01,  Leader TRUE METRIX Meter Only/RE4002-40,  CVS TRUE METRIX Kit/RE4007-01SB,  GNP TRUE METRIX Meter Only/RE4011-00,  GNP TRUE METRIX Kit\t/RE4011-01,  MEIJER TRUE METRIX Kit/RE4019-01,  FRED'S TRUE METRIX Kit/RE4023-01,  DISCOUNT DRUG TRUE METRIX Kit/RE4025-01,  KINRAY TRUE METRIX Kit/RE4027-01,  HEB TRUE METRIX Kit/RE4031-01,  McKesson TRUE METRIX Starter Kit/RE4051-43,  SUNMARK TRUE METRIX Meter Only/RE4054-00,  SUNMARK TRUE METRIX Kit/RE4054-01,  Signature Care TRUE METRIX Kit/RE4060-01,  CareOne TRUE METRIX Kit/RE4061-01,  RITE AID TRUE METRIX Kit/RE4066-01,  Liberty TRUE METRIX Meter Only/RE4078-40,  HUMANA TRUE METRIX Starter Kit/RE4081-03,  Wegmans TRUE METRIX Kit/RE4087-01,  HEALTHMART TRUE METRIX Meter Only/RE4089-00,  HEALTHMART TRUE METRIX Kit/RE4089-01,  ARRIVA TRUE METRIX Meter Only/RE4095-40,  HealthyAccents TRUE METRIX Kit/RE4097-01,  Shopko TRUE METRIX Kit/RE4098-01,  Henry Schein TRUE METRIX Kit/RE4099-40,  Henry Schein TRUE METRIX Meter Only/RE4099-45,  Millennium Pharmay Services TRUE METRIX Kit/RE4202-43,  Kroger TRUE METRIX  Kit/RE4203-01,  TOPCARE TRUE METRIX Kit/RE4209-01,  Foster and Thrive TRUE METRIX Kit/RE4211-01,  TRUE METRIX Meter Only/RE4H01-00,  TRUE METRIX Kit/RE4H01-01,  TRUE METRIX Starter Kit/RE4H01-04,  TRUE METRIX NFRS Meter Only/RE4H01-40,  TRUE METRIX NFRS Starter Kit/RE4H01-43,  TRUE METRIX Kit/RE4H01-51,  TRUE METRIX Meter Only (mg/dL)/RE4i01-00,  TRUE METRIX Kit (mg/dL)/RE4i01-01,  TRUE METRIX Kit (mg/dL)/RE4i01-02,  TRUE METRIX Starter Kit (mg/dL)/RE4i03-02,  TRUE METRIX Kit (mmol/L)/RE4i03-11,  Farmacia Benavides TRUE METRIX Meter Only (Mexico - mg/dL)/RE4i05-00,  Farmacia del Ahorro TRUE METRIX Meter Only (Mexico - mg/dL)/RE4i07-00,  TRUE METRIX Meter Only (Mexico - mg/dL)/RE4i23-00,  TRUE METRIX Meter Only (Jamaica - mmol/L)/RE4i29-11,  TRUE METRIX Kit (mg/dL)/RE4i61-02,  TRUE METRIX Kit (mg/dL)/RE4i61-02THI,  TRUE METRIX Kit (United Kingdom - mmol/L)/RE4i82-11,  TRUE METRIX Starter Kit (United Kingdom - mmol/L)/RE4i82-12.",
      "text": "The FDA logged enforcement record Z-1545-2026: Trividia Health, Inc. is voluntarily recalling Owner's Booklets and Instructions for Use that are used with the following blood glucose measuring devices.   Description/Item:  Walgreens TRUE METRIX Kit/RE4001-01,  Leader TRUE METRIX Kit/RE4002-01,  Leader TRUE METRIX Meter Only/RE4002-40,  CVS TRUE METRIX Kit/RE4007-01SB,  GNP TRUE METRIX Meter Only/RE4011-00,  GNP TRUE METRIX Kit\t/RE4011-01,  MEIJER TRUE METRIX Kit/RE4019-01,  FRED'S TRUE METRIX Kit/RE4023-01,  DISCOUNT DRUG TRUE METRIX Kit/RE4025-01,  KINRAY TRUE METRIX Kit/RE4027-01,  HEB TRUE METRIX Kit/RE4031-01,  McKesson TRUE METRIX Starter Kit/RE4051-43,  SUNMARK TRUE METRIX Meter Only/RE4054-00,  SUNMARK TRUE METRIX Kit/RE4054-01,  Signature Care TRUE METRIX Kit/RE4060-01,  CareOne TRUE METRIX Kit/RE4061-01,  RITE AID TRUE METRIX Kit/RE4066-01,  Liberty TRUE METRIX Meter Only/RE4078-40,  HUMANA TRUE METRIX Starter Kit/RE4081-03,  Wegmans TRUE METRIX Kit/RE4087-01,  HEALTHMART TRUE METRIX Meter Only/RE4089-00,  HEALTHMART TRUE METRIX Kit/RE4089-01,  ARRIVA TRUE METRIX Meter Only/RE4095-40,  HealthyAccents TRUE METRIX Kit/RE4097-01,  Shopko TRUE METRIX Kit/RE4098-01,  Henry Schein TRUE METRIX Kit/RE4099-40,  Henry Schein TRUE METRIX Meter Only/RE4099-45,  Millennium Pharmay Services TRUE METRIX Kit/RE4202-43,  Kroger TRUE METRIX  Kit/RE4203-01,  TOPCARE TRUE METRIX Kit/RE4209-01,  Foster and Thrive TRUE METRIX Kit/RE4211-01,  TRUE METRIX Meter Only/RE4H01-00,  TRUE METRIX Kit/RE4H01-01,  TRUE METRIX Starter Kit/RE4H01-04,  TRUE METRIX NFRS Meter Only/RE4H01-40,  TRUE METRIX NFRS Starter Kit/RE4H01-43,  TRUE METRIX Kit/RE4H01-51,  TRUE METRIX Meter Only (mg/dL)/RE4i01-00,  TRUE METRIX Kit (mg/dL)/RE4i01-01,  TRUE METRIX Kit (mg/dL)/RE4i01-02,  TRUE METRIX Starter Kit (mg/dL)/RE4i03-02,  TRUE METRIX Kit (mmol/L)/RE4i03-11,  Farmacia Benavides TRUE METRIX Meter Only (Mexico - mg/dL)/RE4i05-00,  Farmacia del Ahorro TRUE METRIX Meter Only (Mexico - mg/dL)/RE4i07-00,  TRUE METRIX Meter Only (Mexico - mg/dL)/RE4i23-00,  TRUE METRIX Meter Only (Jamaica - mmol/L)/RE4i29-11,  TRUE METRIX Kit (mg/dL)/RE4i61-02,  TRUE METRIX Kit (mg/dL)/RE4i61-02THI,  TRUE METRIX Kit (United Kingdom - mmol/L)/RE4i82-11,  TRUE METRIX Starter Kit (United Kingdom - mmol/L)/RE4i82-12. — reason: The system labeling (user manual and online labeling) did not provide adequate directions for lay users to act on the E-5 error code. The error code description and recommended actions for the E-5 error code in the labeling do not: (a) clearly emphasize that an E-5 error code could represent a very high blood glucose level, and (b) prominently convey the appropriate immediate actions, such as contacting a healthcare professional. This could lead to a delay in treatment if the user does not seek medical attention immediately when receiving an E-5 error code and experiencing symptoms of high glucose.. Status: Ongoing — the recall is still being carried out.. Initiated 2026-02-06. Affected lots/codes: Device Item/UDI-DI: RE4001-01/00311917166896, RE4002-01/96295126600, RE4002-40/96295126655, RE4007-01SB/50428275283, RE4011-00/87701426520, RE4011-01/87701426254, RE4019-01/713733069816, RE4023-01/21292007256, RE4025-01/93351018992, RE4027-01/21292007065, RE4031-01/41220001286, RE4051-43/20612479197231, RE4054-00/10939722447, RE4054-01/10939719447, RE4060-01/321130788669, RE4061-01/41520147745, RE4066-01/11822445610, RE4078-40/21292007614, RE4081-03/21292014797, RE4087-01/77890394113, RE4089-00/52569138557, RE4089-01/52569138526, RE4095-40/21292007041, RE4097-01/725439988933, RE4098-01/21292008901, RE4099-40/21292014902, RE4099-45/21292008697, RE4202-43/21292007454, RE4203-01/41260016028, RE4209-01/36800234529, RE4211-01/10939958693, RE4H01-00/21292006082, RE4H01-01/21292006051, RE4H01-04/21292008895, RE4H01-40/21292006068, RE4H01-43/21292006075, RE4H01-51/21292014940.  International: RE4i01-00/N/A, RE4i01-01/N/A, RE4i01-02/N/A, RE4i03-02/N/A, RE4i03-11/N/A, RE4i05-00/N/A, RE4i07-00/N/A, RE4i23-00/21292010133, RE4i29-11/N/A, RE4i61-02/N/A, RE4i61-02THI/N/A, RE4i82-11/21292012205, RE4i82-12/21292009977.  Owner's Booklet or IFU Description/Part and Revision: TRUE METRIX Owner's Booklet/ RE4TVH03 Rev 56 and prior, TRUE METRIX Owner's Booklet (English)/ RE4TVH35 Rev 51 and prior,  TRUE METRIX Owner's Booklet (Spanish)/ RE4TVH35S Rev 51 and prior,   McKesson Med Surg TRUE METRIX Self Monitoring Owners Booklet/ RE4SUN03 Rev 55 and prior,  McKesson Med Surg TRUE METRIX PRO Owners Booklet/ RE4SUNP03 Rev 56 and prior,  TRUE METRIX Blood Glucose Monitoring System IFU Trividia House Brand/ RE4ITV16 Rev 53 and prior,  TRUE METRIX System Instructions for Use (IFU) for Trividia Health UK Limited/RE4UKT16 Rev 55 and prior,  Trividia Health LATAM - TRUE METRIX System IFU mg/dL/ RE4LAT16 Rev 50 and prior,  TRUE METRIX System Instructions for Use (IFU) for Trividia Health Australia/ RE4AUT16 Rev 56 and prior.  Device serial numbers: Prefix \"T\" followed by an eight-digit numeric sequence.. A RECORDED FDA enforcement action (occurred=true).",
      "claimType": "official_fact",
      "reviewStatus": "current",
      "commercialInfluence": false,
      "epistemicStatus": {
        "occurred": true,
        "supported": true,
        "adjudged": true,
        "operative": true
      },
      "grounding": {
        "groundingType": "SourceCitation",
        "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-1545-2026&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-1545-2026&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."
    },
    {
      "@id": "https://drug-device-safety-atlas.ryanjhunter.workers.dev/recalls/Z-1545-2026/fda-classification",
      "@type": "schema:Claim",
      "name": "FDA classified recall Z-1545-2026 as Class I",
      "text": "The FDA assigned this recall Class I: Class I — the FDA judged there is a reasonable probability that use of the product would cause serious harm or death.. 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.",
      "claimType": "regulatory_determination",
      "reviewStatus": "current",
      "commercialInfluence": false,
      "epistemicStatus": {
        "occurred": false,
        "supported": true,
        "adjudged": true,
        "operative": true
      },
      "grounding": {
        "groundingType": "AdjudicativeAct",
        "source": "U.S. FDA recall classification (openFDA enforcement)",
        "sourceUrl": "https://www.accessdata.fda.gov/scripts/enforcement/enforce_rpt-Product-Tabs.cfm?action=select&recall_number=Z-1545-2026&lang=eng",
        "value": "Class I",
        "adjudicator": {
          "name": "U.S. FDA recall classification (openFDA enforcement)",
          "url": "https://www.accessdata.fda.gov/scripts/enforcement/enforce_rpt-Product-Tabs.cfm?action=select&recall_number=Z-1545-2026&lang=eng"
        }
      },
      "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-1545-2026/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": {
        "occurred": false,
        "supported": true,
        "adjudged": false,
        "operative": true
      },
      "grounding": {
        "groundingType": "Interpretation",
        "source": "Atlas Commons L5 boundary (enforcement-action ≠ harm causation)",
        "sourceUrl": "https://drug-device-safety-atlas.ryanjhunter.workers.dev/",
        "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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      "name": "FDA recall details — Z-1545-2026",
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          "item": {
            "Field": "Recall number",
            "Value": "Z-1545-2026",
            "Status": "recorded"
          }
        },
        {
          "@type": "schema:ListItem",
          "position": 2,
          "item": {
            "Field": "Product type",
            "Value": "Devices",
            "Status": "recorded"
          }
        },
        {
          "@type": "schema:ListItem",
          "position": 3,
          "item": {
            "Field": "Classification",
            "Value": "Class I",
            "Status": "determination"
          }
        },
        {
          "@type": "schema:ListItem",
          "position": 4,
          "item": {
            "Field": "Status",
            "Value": "Ongoing — the recall is still being carried out.",
            "Status": "recorded"
          }
        },
        {
          "@type": "schema:ListItem",
          "position": 5,
          "item": {
            "Field": "Recalling firm",
            "Value": "Trividia Health, Inc.",
            "Status": "recorded"
          }
        },
        {
          "@type": "schema:ListItem",
          "position": 6,
          "item": {
            "Field": "Reason",
            "Value": "The system labeling (user manual and online labeling) did not provide adequate directions for lay users to act on the E-5 error code. The error code description and recommended actions for the E-5 error code in the labeling do not: (a) clearly emphasize that an E-5 error code could represent a very high blood glucose level, and (b) prominently convey the appropriate immediate actions, such as contacting a healthcare professional. This could lead to a delay in treatment if the user does not seek medical attention immediately when receiving an E-5 error code and experiencing symptoms of high glucose.",
            "Status": "recorded"
          }
        },
        {
          "@type": "schema:ListItem",
          "position": 7,
          "item": {
            "Field": "Initiated",
            "Value": "2026-02-06",
            "Status": "recorded"
          }
        },
        {
          "@type": "schema:ListItem",
          "position": 8,
          "item": {
            "Field": "Lot/code info",
            "Value": "Device Item/UDI-DI: RE4001-01/00311917166896, RE4002-01/96295126600, RE4002-40/96295126655, RE4007-01SB/50428275283, RE4011-00/87701426520, RE4011-01/87701426254, RE4019-01/713733069816, RE4023-01/21292007256, RE4025-01/93351018992, RE4027-01/21292007065, RE4031-01/41220001286, RE4051-43/20612479197231, RE4054-00/10939722447, RE4054-01/10939719447, RE4060-01/321130788669, RE4061-01/41520147745, RE4066-01/11822445610, RE4078-40/21292007614, RE4081-03/21292014797, RE4087-01/77890394113, RE4089-00/52569138557, RE4089-01/52569138526, RE4095-40/21292007041, RE4097-01/725439988933, RE4098-01/21292008901, RE4099-40/21292014902, RE4099-45/21292008697, RE4202-43/21292007454, RE4203-01/41260016028, RE4209-01/36800234529, RE4211-01/10939958693, RE4H01-00/21292006082, RE4H01-01/21292006051, RE4H01-04/21292008895, RE4H01-40/21292006068, RE4H01-43/21292006075, RE4H01-51/21292014940.  International: RE4i01-00/N/A, RE4i01-01/N/A, RE4i01-02/N/A, RE4i03-02/N/A, RE4i03-11/N/A, RE4i05-00/N/A, RE4i07-00/N/A, RE4i23-00/21292010133, RE4i29-11/N/A, RE4i61-02/N/A, RE4i61-02THI/N/A, RE4i82-11/21292012205, RE4i82-12/21292009977.  Owner's Booklet or IFU Description/Part and Revision: TRUE METRIX Owner's Booklet/ RE4TVH03 Rev 56 and prior, TRUE METRIX Owner's Booklet (English)/ RE4TVH35 Rev 51 and prior,  TRUE METRIX Owner's Booklet (Spanish)/ RE4TVH35S Rev 51 and prior,   McKesson Med Surg TRUE METRIX Self Monitoring Owners Booklet/ RE4SUN03 Rev 55 and prior,  McKesson Med Surg TRUE METRIX PRO Owners Booklet/ RE4SUNP03 Rev 56 and prior,  TRUE METRIX Blood Glucose Monitoring System IFU Trividia House Brand/ RE4ITV16 Rev 53 and prior,  TRUE METRIX System Instructions for Use (IFU) for Trividia Health UK Limited/RE4UKT16 Rev 55 and prior,  Trividia Health LATAM - TRUE METRIX System IFU mg/dL/ RE4LAT16 Rev 50 and prior,  TRUE METRIX System Instructions for Use (IFU) for Trividia Health Australia/ RE4AUT16 Rev 56 and prior.  Device serial numbers: Prefix \"T\" followed by an eight-digit numeric sequence.",
            "Status": "recorded"
          }
        },
        {
          "@type": "schema:ListItem",
          "position": 9,
          "item": {
            "Field": "Distribution pattern",
            "Value": "Worldwide distribution - US Nationwide including Puerto Rico and the countries of Mexico, United Kingdom, Jamaica, Trinidad & Tobago, and Australia.",
            "Status": "recorded"
          }
        }
      ]
    }
  ]
}