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  "@id": "https://drug-device-safety-atlas.ryanjhunter.workers.dev/recalls/Z-1548-2026.jsonld",
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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 GO Kit/RF4001-01BK,  CVS TRUE METRIX GO Kit/RF4007-01,  Meijer TRUE METRIX GO Kit/RF4019-01,  Fred's Phamarcy TRUE METRIX GO Kit/RF4023-01,  HEB TRUE METRIX GO Kit/RF4031-01,  Hyvee TRUE METRIX GO Kit/RF4048-01,  Rite Aid TRUE METRIX GO Kit/RF4066-01,  TopCo TRUE METRIX GO Kit/RF4209-01,  TRUE METRIX GO  Kit/RF4H01-01BK,  TRUE METRIX GO  NFRS Meter Only/RF4H01-40,  TRUE METRIX GO Kit (Jamaica - mmol/L)/RF4i29-11BK,  TRUE METRIX GO Kit (Australia - mmol/L)/RF4i81-11BK,  TRUE METRIX GO Kit (United Kingdom - mmol/L)/RF4i82-11BK,  TRUE METRIX GO Starter Kit (United Kingdom - mmol/L)/RF4i82-12BK",
  "description": "FDA recall Z-1548-2026 — 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 GO Kit/RF4001-01BK,  CVS TRUE METRIX GO Kit/RF4007-01,  Meijer TRUE METRIX GO Kit/RF4019-01,  Fred's Phamarcy TRUE METRIX GO Kit/RF4023-01,  HEB TRUE METRIX GO Kit/RF4031-01,  Hyvee TRUE METRIX GO Kit/RF4048-01,  Rite Aid TRUE METRIX GO Kit/RF4066-01,  TopCo TRUE METRIX GO Kit/RF4209-01,  TRUE METRIX GO  Kit/RF4H01-01BK,  TRUE METRIX GO  NFRS Meter Only/RF4H01-40,  TRUE METRIX GO Kit (Jamaica - mmol/L)/RF4i29-11BK,  TRUE METRIX GO Kit (Australia - mmol/L)/RF4i81-11BK,  TRUE METRIX GO Kit (United Kingdom - mmol/L)/RF4i82-11BK,  TRUE METRIX GO Starter Kit (United Kingdom - mmol/L)/RF4i82-12BK (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.",
  "license": "https://creativecommons.org/publicdomain/zero/1.0/",
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  "dateModified": "2026-06-24T07:02:03.626072+00:00",
  "isBasedOn": {
    "@type": "schema:Dataset",
    "name": "openFDA drug & device enforcement (recall) reports",
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      "name": "U.S. Food & Drug Administration"
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  "sameAs": "https://www.accessdata.fda.gov/scripts/enforcement/enforce_rpt-Product-Tabs.cfm?action=select&recall_number=Z-1548-2026&lang=eng",
  "about": {
    "@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 GO Kit/RF4001-01BK,  CVS TRUE METRIX GO Kit/RF4007-01,  Meijer TRUE METRIX GO Kit/RF4019-01,  Fred's Phamarcy TRUE METRIX GO Kit/RF4023-01,  HEB TRUE METRIX GO Kit/RF4031-01,  Hyvee TRUE METRIX GO Kit/RF4048-01,  Rite Aid TRUE METRIX GO Kit/RF4066-01,  TopCo TRUE METRIX GO Kit/RF4209-01,  TRUE METRIX GO  Kit/RF4H01-01BK,  TRUE METRIX GO  NFRS Meter Only/RF4H01-40,  TRUE METRIX GO Kit (Jamaica - mmol/L)/RF4i29-11BK,  TRUE METRIX GO Kit (Australia - mmol/L)/RF4i81-11BK,  TRUE METRIX GO Kit (United Kingdom - mmol/L)/RF4i82-11BK,  TRUE METRIX GO Starter Kit (United Kingdom - mmol/L)/RF4i82-12BK",
    "manufacturer": {
      "@type": "schema:Organization",
      "name": "Trividia Health, Inc."
    }
  },
  "claims": [
    {
      "@id": "https://drug-device-safety-atlas.ryanjhunter.workers.dev/recalls/Z-1548-2026/enforcement-record",
      "@type": "schema:Claim",
      "name": "FDA recall Z-1548-2026: 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 GO Kit/RF4001-01BK,  CVS TRUE METRIX GO Kit/RF4007-01,  Meijer TRUE METRIX GO Kit/RF4019-01,  Fred's Phamarcy TRUE METRIX GO Kit/RF4023-01,  HEB TRUE METRIX GO Kit/RF4031-01,  Hyvee TRUE METRIX GO Kit/RF4048-01,  Rite Aid TRUE METRIX GO Kit/RF4066-01,  TopCo TRUE METRIX GO Kit/RF4209-01,  TRUE METRIX GO  Kit/RF4H01-01BK,  TRUE METRIX GO  NFRS Meter Only/RF4H01-40,  TRUE METRIX GO Kit (Jamaica - mmol/L)/RF4i29-11BK,  TRUE METRIX GO Kit (Australia - mmol/L)/RF4i81-11BK,  TRUE METRIX GO Kit (United Kingdom - mmol/L)/RF4i82-11BK,  TRUE METRIX GO Starter Kit (United Kingdom - mmol/L)/RF4i82-12BK",
      "text": "The FDA logged enforcement record Z-1548-2026: 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 GO Kit/RF4001-01BK,  CVS TRUE METRIX GO Kit/RF4007-01,  Meijer TRUE METRIX GO Kit/RF4019-01,  Fred's Phamarcy TRUE METRIX GO Kit/RF4023-01,  HEB TRUE METRIX GO Kit/RF4031-01,  Hyvee TRUE METRIX GO Kit/RF4048-01,  Rite Aid TRUE METRIX GO Kit/RF4066-01,  TopCo TRUE METRIX GO Kit/RF4209-01,  TRUE METRIX GO  Kit/RF4H01-01BK,  TRUE METRIX GO  NFRS Meter Only/RF4H01-40,  TRUE METRIX GO Kit (Jamaica - mmol/L)/RF4i29-11BK,  TRUE METRIX GO Kit (Australia - mmol/L)/RF4i81-11BK,  TRUE METRIX GO Kit (United Kingdom - mmol/L)/RF4i82-11BK,  TRUE METRIX GO Starter Kit (United Kingdom - mmol/L)/RF4i82-12BK — 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:  RF4001-01BK/311917178691, RF4007-01/50428560402, RF4019-01/708820721098, RF4023-01/21292009335, RF4031-01/41220136131, RF4048-01/75450843576, RF4066-01/11822002783, RF4209-01/36800234567, RF4H01-01BK/21292006112, RF4H01-40/21292009793.  International: RF4i29-11BK/N/A, RF4i81-11BK/N/A, RF4i82-11BK/21292012229, RF4i82-12BK/21292009984.  Owner's Booklet or IFU Description/Part and Revision: TRUE METRIX GO Owner's Booklet/ RF4TVH03 Rev 57 and prior,  TRUE METRIX GO Owner's Booklet (English)/RF4TVH35 Rev 51 and prior, TRUE METRIX GO Owner's Booklet (Spanish)/RF4TVH35S Rev 51 and prior, TRUE METRIX GO Blood Glucose Monitoring System IFU Trividia House Brand/ RF4ITV16 Rev 55 and prior,  TRUE METRIX GO System Instructions for Use (IFU) for Trividia Health UK Limited/ RF4UKT16 Rev 56 and prior,  Trividia Health LATAM- TRUE METRIX GO System IFU/ RF4LAT16 Rev 51 and prior,  TRUE METRIX GO System Instructions for Use (IFU) for Trividia Health Australia/ RF4AUT16 Rev 57 and prior.  Device serial numbers: Prefix \"F\" 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
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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-1548-2026&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-1548-2026&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-1548-2026/fda-classification",
      "@type": "schema:Claim",
      "name": "FDA classified recall Z-1548-2026 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
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      "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-1548-2026&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-1548-2026&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-1548-2026/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
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      "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-1548-2026",
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          "position": 1,
          "item": {
            "Field": "Recall number",
            "Value": "Z-1548-2026",
            "Status": "recorded"
          }
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          "@type": "schema:ListItem",
          "position": 2,
          "item": {
            "Field": "Product type",
            "Value": "Devices",
            "Status": "recorded"
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          "position": 3,
          "item": {
            "Field": "Classification",
            "Value": "Class I",
            "Status": "determination"
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          "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:  RF4001-01BK/311917178691, RF4007-01/50428560402, RF4019-01/708820721098, RF4023-01/21292009335, RF4031-01/41220136131, RF4048-01/75450843576, RF4066-01/11822002783, RF4209-01/36800234567, RF4H01-01BK/21292006112, RF4H01-40/21292009793.  International: RF4i29-11BK/N/A, RF4i81-11BK/N/A, RF4i82-11BK/21292012229, RF4i82-12BK/21292009984.  Owner's Booklet or IFU Description/Part and Revision: TRUE METRIX GO Owner's Booklet/ RF4TVH03 Rev 57 and prior,  TRUE METRIX GO Owner's Booklet (English)/RF4TVH35 Rev 51 and prior, TRUE METRIX GO Owner's Booklet (Spanish)/RF4TVH35S Rev 51 and prior, TRUE METRIX GO Blood Glucose Monitoring System IFU Trividia House Brand/ RF4ITV16 Rev 55 and prior,  TRUE METRIX GO System Instructions for Use (IFU) for Trividia Health UK Limited/ RF4UKT16 Rev 56 and prior,  Trividia Health LATAM- TRUE METRIX GO System IFU/ RF4LAT16 Rev 51 and prior,  TRUE METRIX GO System Instructions for Use (IFU) for Trividia Health Australia/ RF4AUT16 Rev 57 and prior.  Device serial numbers: Prefix \"F\" followed by an eight-digit numeric sequence.",
            "Status": "recorded"
          }
        },
        {
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          "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"
          }
        }
      ]
    }
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}