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  "@id": "https://drug-device-safety-atlas.ryanjhunter.workers.dev/recalls/Z-2351-2024.jsonld",
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  "name": "BD Multitest 6-Color TBNK CE-IVD, REF: 644611;  BD Multitest 6-Color TBNK Kit with BD Trucount Tubes CE-IVD, REF: 337166;  BD Multitest 6-Color TBNK, IVD, REF: 662967;  BD Multitest 6-Color TBNK Kit with BD Trucount Tubes IVD, REF: 662995.   BD Multitest\" 6-Color TBNK reagent with optional BD Trucount\" Tubes is a six-color direct immunofluorescence reagent.",
  "description": "FDA recall Z-2351-2024 — Becton, Dickinson and Company, BD Biosciences is recalling BD Multitest 6-Color TBNK CE-IVD, REF: 644611;  BD Multitest 6-Color TBNK Kit with BD Trucount Tubes CE-IVD, REF: 337166;  BD Multitest 6-Color TBNK, IVD, REF: 662967;  BD Multitest 6-Color TBNK Kit with BD Trucount Tubes IVD, REF: 662995.   BD Multitest\" 6-Color TBNK reagent with optional BD Trucount\" Tubes is a six-color direct immunofluorescence reagent. (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.",
  "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",
    "url": "https://open.fda.gov/apis/drug/enforcement/",
    "creator": {
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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-2351-2024&lang=eng",
  "about": {
    "@type": "schema:MedicalDevice",
    "name": "BD Multitest 6-Color TBNK CE-IVD, REF: 644611;  BD Multitest 6-Color TBNK Kit with BD Trucount Tubes CE-IVD, REF: 337166;  BD Multitest 6-Color TBNK, IVD, REF: 662967;  BD Multitest 6-Color TBNK Kit with BD Trucount Tubes IVD, REF: 662995.   BD Multitest\" 6-Color TBNK reagent with optional BD Trucount\" Tubes is a six-color direct immunofluorescence reagent.",
    "manufacturer": {
      "@type": "schema:Organization",
      "name": "Becton, Dickinson and Company, BD Biosciences"
    }
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  "claims": [
    {
      "@id": "https://drug-device-safety-atlas.ryanjhunter.workers.dev/recalls/Z-2351-2024/enforcement-record",
      "@type": "schema:Claim",
      "name": "FDA recall Z-2351-2024: Becton, Dickinson and Company, BD Biosciences is recalling BD Multitest 6-Color TBNK CE-IVD, REF: 644611;  BD Multitest 6-Color TBNK Kit with BD Trucount Tubes CE-IVD, REF: 337166;  BD Multitest 6-Color TBNK, IVD, REF: 662967;  BD Multitest 6-Color TBNK Kit with BD Trucount Tubes IVD, REF: 662995.   BD Multitest\" 6-Color TBNK reagent with optional BD Trucount\" Tubes is a six-color direct immunofluorescence reagent.",
      "text": "The FDA logged enforcement record Z-2351-2024: Becton, Dickinson and Company, BD Biosciences is voluntarily recalling BD Multitest 6-Color TBNK CE-IVD, REF: 644611;  BD Multitest 6-Color TBNK Kit with BD Trucount Tubes CE-IVD, REF: 337166;  BD Multitest 6-Color TBNK, IVD, REF: 662967;  BD Multitest 6-Color TBNK Kit with BD Trucount Tubes IVD, REF: 662995.   BD Multitest\" 6-Color TBNK reagent with optional BD Trucount\" Tubes is a six-color direct immunofluorescence reagent. — reason: Multitest with compromised raw material used to assess immune system status may result in flow cytometry plot with unusual staining pattern, nonspecific aggregates, high background, double positive event increase on CD3+CD4+vsCD3+CD8+ and/or CD3-CD16+CD56+vsCD3-CD19+, contaminated antibodies, may lead to erroneous or delayed results, additional patient sample, might impact healthcare decisions. Status: Ongoing — the recall is still being carried out.. Initiated 2024-05-08. Affected lots/codes: REF/UDI-DI/Lot-Expiration: 644611/382906446114/20010-31-Aug-24, 49510-30-Sep-24, 32674-30-Sep-24; 337166/382903371662/17569-31-Jul-24, 22709-31-Aug-24, 49517-30-Sep-24; 662967/382906629678/17572-31-Jul-24, 17582-31-Jul-24, 26797-31-Aug-24, 69761-30-Sep-24, 49506-30-Sep-24; 662995/382906629951/49508-30-Sep-24. 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-2351-2024&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-2351-2024&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."
    },
    {
      "@id": "https://drug-device-safety-atlas.ryanjhunter.workers.dev/recalls/Z-2351-2024/fda-classification",
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      "name": "FDA classified recall Z-2351-2024 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.",
      "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-2351-2024&lang=eng",
        "value": "Class II",
        "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-2351-2024&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-2351-2024/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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        "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-2351-2024",
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            "Value": "Z-2351-2024",
            "Status": "recorded"
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          "item": {
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            "Value": "Devices",
            "Status": "recorded"
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          "item": {
            "Field": "Classification",
            "Value": "Class II",
            "Status": "determination"
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            "Field": "Status",
            "Value": "Ongoing — the recall is still being carried out.",
            "Status": "recorded"
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          "position": 5,
          "item": {
            "Field": "Recalling firm",
            "Value": "Becton, Dickinson and Company, BD Biosciences",
            "Status": "recorded"
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          "item": {
            "Field": "Reason",
            "Value": "Multitest with compromised raw material used to assess immune system status may result in flow cytometry plot with unusual staining pattern, nonspecific aggregates, high background, double positive event increase on CD3+CD4+vsCD3+CD8+ and/or CD3-CD16+CD56+vsCD3-CD19+, contaminated antibodies, may lead to erroneous or delayed results, additional patient sample, might impact healthcare decisions",
            "Status": "recorded"
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          "item": {
            "Field": "Initiated",
            "Value": "2024-05-08",
            "Status": "recorded"
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          "item": {
            "Field": "Lot/code info",
            "Value": "REF/UDI-DI/Lot-Expiration: 644611/382906446114/20010-31-Aug-24, 49510-30-Sep-24, 32674-30-Sep-24; 337166/382903371662/17569-31-Jul-24, 22709-31-Aug-24, 49517-30-Sep-24; 662967/382906629678/17572-31-Jul-24, 17582-31-Jul-24, 26797-31-Aug-24, 69761-30-Sep-24, 49506-30-Sep-24; 662995/382906629951/49508-30-Sep-24",
            "Status": "recorded"
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          "item": {
            "Field": "Distribution pattern",
            "Value": "US: MN, NJ, NY, MD, UT, FL, NC, MA, KY, NE, NV, CA, LA, DC, OH, MI, PA, WA, CT, AL, DE, TN, IN, OR, IL, WI, NH, TX, GA, RI, SD, ID, NM, AR.  OUS: CA, SG, NZ, AU, KR, IN, PE, GT, AR, MX, TW, CN, NI, CR, JP, BR, TH, BE, VN",
            "Status": "recorded"
          }
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}