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  "@id": "https://drug-device-safety-atlas.ryanjhunter.workers.dev/recalls/Z-1464-2024.jsonld",
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  "name": "VITEK 2 - AST Test kits (in vitro diagnostic test cards for antimicrobial susceptibility):    a) AST-N334, REF 418984;   b) AST-GN95, REF 421982;   c) AST-GN99, REF 423102;   d) AST-N390, REF 423340;   e) AST-N391, REF 423341;   f) AST-N392, REF 423342;   g) AST-N395, REF 423491;   h) AST-N401, REF 423643;   i) AST-N402, REF 423644;   j) AST-N404, REF 423664;   k) AST-N802, REF 423706;   l) AST-N405, REF 423864;   m) AST-N417, REF 423880;   n) AST-N408, REF 423924;   o) AST-N409, REF 423925;   p) AST-N420, REF 424039;   q) AST-N423, REF 424042;   r) AST-N422, REF 424056;   s) AST-N436, REF 424440;   t) AST-N809, REF 424703;   u) AST-N806, REF 424709;   v) AST-N807, REF 424710;   w) AST-N808, REF 424711;   x) AST-N810, REF 424712;   y) AST-N812, REF 424721",
  "description": "FDA recall Z-1464-2024 — Biomerieux Inc is recalling VITEK 2 - AST Test kits (in vitro diagnostic test cards for antimicrobial susceptibility):    a) AST-N334, REF 418984;   b) AST-GN95, REF 421982;   c) AST-GN99, REF 423102;   d) AST-N390, REF 423340;   e) AST-N391, REF 423341;   f) AST-N392, REF 423342;   g) AST-N395, REF 423491;   h) AST-N401, REF 423643;   i) AST-N402, REF 423644;   j) AST-N404, REF 423664;   k) AST-N802, REF 423706;   l) AST-N405, REF 423864;   m) AST-N417, REF 423880;   n) AST-N408, REF 423924;   o) AST-N409, REF 423925;   p) AST-N420, REF 424039;   q) AST-N423, REF 424042;   r) AST-N422, REF 424056;   s) AST-N436, REF 424440;   t) AST-N809, REF 424703;   u) AST-N806, REF 424709;   v) AST-N807, REF 424710;   w) AST-N808, REF 424711;   x) AST-N810, REF 424712;   y) AST-N812, REF 424721 (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": "VITEK 2 - AST Test kits (in vitro diagnostic test cards for antimicrobial susceptibility):    a) AST-N334, REF 418984;   b) AST-GN95, REF 421982;   c) AST-GN99, REF 423102;   d) AST-N390, REF 423340;   e) AST-N391, REF 423341;   f) AST-N392, REF 423342;   g) AST-N395, REF 423491;   h) AST-N401, REF 423643;   i) AST-N402, REF 423644;   j) AST-N404, REF 423664;   k) AST-N802, REF 423706;   l) AST-N405, REF 423864;   m) AST-N417, REF 423880;   n) AST-N408, REF 423924;   o) AST-N409, REF 423925;   p) AST-N420, REF 424039;   q) AST-N423, REF 424042;   r) AST-N422, REF 424056;   s) AST-N436, REF 424440;   t) AST-N809, REF 424703;   u) AST-N806, REF 424709;   v) AST-N807, REF 424710;   w) AST-N808, REF 424711;   x) AST-N810, REF 424712;   y) AST-N812, REF 424721",
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      "name": "Biomerieux Inc"
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    {
      "@id": "https://drug-device-safety-atlas.ryanjhunter.workers.dev/recalls/Z-1464-2024/enforcement-record",
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      "name": "FDA recall Z-1464-2024: Biomerieux Inc is recalling VITEK 2 - AST Test kits (in vitro diagnostic test cards for antimicrobial susceptibility):    a) AST-N334, REF 418984;   b) AST-GN95, REF 421982;   c) AST-GN99, REF 423102;   d) AST-N390, REF 423340;   e) AST-N391, REF 423341;   f) AST-N392, REF 423342;   g) AST-N395, REF 423491;   h) AST-N401, REF 423643;   i) AST-N402, REF 423644;   j) AST-N404, REF 423664;   k) AST-N802, REF 423706;   l) AST-N405, REF 423864;   m) AST-N417, REF 423880;   n) AST-N408, REF 423924;   o) AST-N409, REF 423925;   p) AST-N420, REF 424039;   q) AST-N423, REF 424042;   r) AST-N422, REF 424056;   s) AST-N436, REF 424440;   t) AST-N809, REF 424703;   u) AST-N806, REF 424709;   v) AST-N807, REF 424710;   w) AST-N808, REF 424711;   x) AST-N810, REF 424712;   y) AST-N812, REF 424721",
      "text": "The FDA logged enforcement record Z-1464-2024: Biomerieux Inc is voluntarily recalling VITEK 2 - AST Test kits (in vitro diagnostic test cards for antimicrobial susceptibility):    a) AST-N334, REF 418984;   b) AST-GN95, REF 421982;   c) AST-GN99, REF 423102;   d) AST-N390, REF 423340;   e) AST-N391, REF 423341;   f) AST-N392, REF 423342;   g) AST-N395, REF 423491;   h) AST-N401, REF 423643;   i) AST-N402, REF 423644;   j) AST-N404, REF 423664;   k) AST-N802, REF 423706;   l) AST-N405, REF 423864;   m) AST-N417, REF 423880;   n) AST-N408, REF 423924;   o) AST-N409, REF 423925;   p) AST-N420, REF 424039;   q) AST-N423, REF 424042;   r) AST-N422, REF 424056;   s) AST-N436, REF 424440;   t) AST-N809, REF 424703;   u) AST-N806, REF 424709;   v) AST-N807, REF 424710;   w) AST-N808, REF 424711;   x) AST-N810, REF 424712;   y) AST-N812, REF 424721 — reason: Ceftriaxone (cro02n) concentration errors associated with specific recently manufactured test kits which would have the potential for for false susceptible results.  The risk is present for isolates that have a result of MIC=0.5, 1, 2.. Status: Ongoing — the recall is still being carried out.. Initiated 2024-03-14. Affected lots/codes: a) AST-N334, REF 418984, UDI/DI 3573026490720, Lot/Serial Numbers:  7742790503, 7742805403, 7742828503, 7742830203;   b) AST-GN95, REF 421982, UDI/DI 3573026565923, Lot/Serial Numbers:   6852740103, 6852751503, 6852778503, 6852811503;   c) AST-GN99, REF 423102, UDI/DI 3573026608132, Lot/Serial Numbers:  6892721103, 6892727403, 6892740503, 6892740403, 6892743503, 6892761503, 6892770403, 6892790103, 6892799403, 6892799103, 6892810103, 6892818103, 6892831503;   d) AST-N390, REF 423340, UDI/DI 3573026612177, Lot/Serial Numbers:  1402832104, 1402761504;   e) AST-N391, REF 423341, UDI/DI 3573026612269, Lot/Serial Numbers:  1412831104, 1412754504;   f) AST-N392, REF 423342, UDI/DI 3573026612283, Lot/Serial Numbers:  1422819204;   g) AST-N395, REF 423491, UDI/DI 3573026615802, Lot/Serial Numbers:  1452725204;   h) AST-N401, REF 423643, UDI/DI 3573026616816, Lot/Serial Numbers:  1512776404, 1512789204, 1512811104, 1512831104, 1512720404, 1512729404, 1512729104, 1512748504, 1512754104, 1512785404;   i) AST-N402, REF 423644, UDI/DI 3573026616830, Lot/Serial Numbers:  1522720504, 1522733404;   j) AST-N404, REF 423664, UDI/DI 3573026617356, Lot/Serial Numbers:  1542819204;   k) AST-N802, REF 423706, UDI/DI 3573026617752, Lot/Serial Numbers: 0422750104, 0422763104, 0422764504, 0422782404, 0422820504, 0422820404;   l) AST-N405, REF 423864, UDI/DI 3573026621360, Lot/Serial Numbers:  1552757504, 1552792404, 1552800404, 1552820104, 1552733104, 1552741504, 1552757404;   m) AST-N417, REF 423880, UDI/DI 3573026621704, Lot/Serial Numbers: 0192763504, 0192819404;   n) AST-N408, REF 423924, UDI/DI 3573026622725, Lot/Serial Numbers:   1582810504, 1582820104, 1582734404, 1582742504, 1582764404, 1582782504;   o) AST-N409, REF 423925, UDI/DI 3573026622749, Lot/Serial Numbers:  1592811104, 1592746404;    p) AST-N420, REF 424039, UDI/DI 3573026625283, Lot/Serial Numbers:  0462810404;    q) AST-N423, REF 424042, UDI/DI 3573026625337, Lot/Serial Numbers:  0502750404, 0502825504;    r) AST-N422, REF 424056, UDI/DI 3573026625610, Lot/Serial Numbers:  0482819504;    s) AST-N436, REF 424440, UDI/DI 3573026631666, Lot/Serial Numbers:  0672734104, 0672754104;   t) AST-N809, REF 424703, UDI/DI 3573026635978, Lot/Serial Numbers:  0962799404;    u) AST-N806, REF 424709, UDI/DI 3573026636067, Lot/Serial Numbers:  0932729404;   v) AST-N807, REF 424710, UDI/DI 3573026636081, Lot/Serial Numbers:  0942723404;   w) AST-N808, REF 424711, UDI/DI 3573026636104, Lot/Serial Numbers: 0952758104;    x) AST-N810, REF 424712, UDI/DI 3573026636128, Lot/Serial Numbers:  0972729504;    y) AST-N812, REF 424721, UDI/DI 3573026636296, Lot/Serial Numbers:  0992777104, 0992776504, 0992821404. A RECORDED FDA enforcement action (occurred=true).",
      "claimType": "official_fact",
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        "sourceUrl": "https://www.accessdata.fda.gov/scripts/enforcement/enforce_rpt-Product-Tabs.cfm?action=select&recall_number=Z-1464-2024&lang=eng",
        "value": "Devices recall, status Ongoing",
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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-1464-2024/fda-classification",
      "@type": "schema:Claim",
      "name": "FDA classified recall Z-1464-2024 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.",
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        "source": "U.S. FDA recall classification (openFDA enforcement)",
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        "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-1464-2024&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-1464-2024/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": {
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        "supported": 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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            "Field": "Recall number",
            "Value": "Z-1464-2024",
            "Status": "recorded"
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          "position": 2,
          "item": {
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            "Value": "Devices",
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          "item": {
            "Field": "Classification",
            "Value": "Class I",
            "Status": "determination"
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            "Value": "Ongoing — the recall is still being carried out.",
            "Status": "recorded"
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          "position": 5,
          "item": {
            "Field": "Recalling firm",
            "Value": "Biomerieux Inc",
            "Status": "recorded"
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          "position": 6,
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            "Field": "Reason",
            "Value": "Ceftriaxone (cro02n) concentration errors associated with specific recently manufactured test kits which would have the potential for for false susceptible results.  The risk is present for isolates that have a result of MIC=0.5, 1, 2.",
            "Status": "recorded"
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          "item": {
            "Field": "Initiated",
            "Value": "2024-03-14",
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            "Field": "Lot/code info",
            "Value": "a) AST-N334, REF 418984, UDI/DI 3573026490720, Lot/Serial Numbers:  7742790503, 7742805403, 7742828503, 7742830203;   b) AST-GN95, REF 421982, UDI/DI 3573026565923, Lot/Serial Numbers:   6852740103, 6852751503, 6852778503, 6852811503;   c) AST-GN99, REF 423102, UDI/DI 3573026608132, Lot/Serial Numbers:  6892721103, 6892727403, 6892740503, 6892740403, 6892743503, 6892761503, 6892770403, 6892790103, 6892799403, 6892799103, 6892810103, 6892818103, 6892831503;   d) AST-N390, REF 423340, UDI/DI 3573026612177, Lot/Serial Numbers:  1402832104, 1402761504;   e) AST-N391, REF 423341, UDI/DI 3573026612269, Lot/Serial Numbers:  1412831104, 1412754504;   f) AST-N392, REF 423342, UDI/DI 3573026612283, Lot/Serial Numbers:  1422819204;   g) AST-N395, REF 423491, UDI/DI 3573026615802, Lot/Serial Numbers:  1452725204;   h) AST-N401, REF 423643, UDI/DI 3573026616816, Lot/Serial Numbers:  1512776404, 1512789204, 1512811104, 1512831104, 1512720404, 1512729404, 1512729104, 1512748504, 1512754104, 1512785404;   i) AST-N402, REF 423644, UDI/DI 3573026616830, Lot/Serial Numbers:  1522720504, 1522733404;   j) AST-N404, REF 423664, UDI/DI 3573026617356, Lot/Serial Numbers:  1542819204;   k) AST-N802, REF 423706, UDI/DI 3573026617752, Lot/Serial Numbers: 0422750104, 0422763104, 0422764504, 0422782404, 0422820504, 0422820404;   l) AST-N405, REF 423864, UDI/DI 3573026621360, Lot/Serial Numbers:  1552757504, 1552792404, 1552800404, 1552820104, 1552733104, 1552741504, 1552757404;   m) AST-N417, REF 423880, UDI/DI 3573026621704, Lot/Serial Numbers: 0192763504, 0192819404;   n) AST-N408, REF 423924, UDI/DI 3573026622725, Lot/Serial Numbers:   1582810504, 1582820104, 1582734404, 1582742504, 1582764404, 1582782504;   o) AST-N409, REF 423925, UDI/DI 3573026622749, Lot/Serial Numbers:  1592811104, 1592746404;    p) AST-N420, REF 424039, UDI/DI 3573026625283, Lot/Serial Numbers:  0462810404;    q) AST-N423, REF 424042, UDI/DI 3573026625337, Lot/Serial Numbers:  0502750404, 0502825504;    r) AST-N422, REF 424056, UDI/DI 3573026625610, Lot/Serial Numbers:  0482819504;    s) AST-N436, REF 424440, UDI/DI 3573026631666, Lot/Serial Numbers:  0672734104, 0672754104;   t) AST-N809, REF 424703, UDI/DI 3573026635978, Lot/Serial Numbers:  0962799404;    u) AST-N806, REF 424709, UDI/DI 3573026636067, Lot/Serial Numbers:  0932729404;   v) AST-N807, REF 424710, UDI/DI 3573026636081, Lot/Serial Numbers:  0942723404;   w) AST-N808, REF 424711, UDI/DI 3573026636104, Lot/Serial Numbers: 0952758104;    x) AST-N810, REF 424712, UDI/DI 3573026636128, Lot/Serial Numbers:  0972729504;    y) AST-N812, REF 424721, UDI/DI 3573026636296, Lot/Serial Numbers:  0992777104, 0992776504, 0992821404",
            "Status": "recorded"
          }
        },
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          "position": 9,
          "item": {
            "Field": "Distribution pattern",
            "Value": "Worldwide",
            "Status": "recorded"
          }
        }
      ]
    }
  ]
}