{
  "@context": {
    "schema": "https://schema.org/",
    "au": "https://drug-device-safety-atlas.ryanjhunter.workers.dev/vocab/agent-native#",
    "@vocab": "https://schema.org/",
    "claims": {
      "@id": "au:claims",
      "@container": "@list"
    },
    "epistemicStatus": "au:epistemicStatus",
    "occurred": "au:occurred",
    "supported": "au:supported",
    "adjudged": "au:adjudged",
    "operative": "au:operative",
    "grounding": "au:grounding",
    "groundingType": "au:groundingType",
    "adjudicator": "au:adjudicator",
    "source": "au:source",
    "sourceUrl": "au:sourceUrl",
    "value": "au:value",
    "claimType": "au:claimType",
    "reviewStatus": "au:reviewStatus",
    "commercialInfluence": "au:commercialInfluence",
    "falsifier": "au:falsifier"
  },
  "@id": "https://drug-device-safety-atlas.ryanjhunter.workers.dev/recalls/Z-1236-2026.jsonld",
  "@type": "schema:Dataset",
  "name": "VITEK 2 Gram-negative Susceptibility Cards Containing o\tPolymyxin B (pb02n) o\tCeftazidime/avibactam (cza02n) o\tMeropenem/Vaborbactam (mev01n) o\tImipenem (ipm05n) o\tImipenem/Relebactam (ipr01n);  CARD NAME/ PRODUCT REFERENCE:  AST-N399  \t423701  AST-N402  \t423644  AST-N403  \t423645  AST-N404  \t423664  AST-N405  \t423864  AST-N406  \t423869  AST-N407  \t423870  AST-N409  \t423925  AST-N412  \t423936  AST-N413  \t423928  AST-N414  \t423933  AST-N415  \t423934  AST-N416  \t423935  AST-N417  \t423880  AST-N419  \t423948  AST-N421  \t424055  AST-N428  \t424320  AST-N429  \t424321  AST-N430  \t424322  AST-N433  \t424389  AST-N439  \t424501  AST-N440  \t424502  AST-N443  \t424541  AST-N444  \t424587  AST-N467  \t424857  AST-N476  \t424934  AST-N478  \t425052  AST-N480 \t425084  AST-N481  \t425085  AST-N485 \t425182  AST-N496 \t425265  AST-N800  \t423310  AST-N802  \t423706  AST-N804  \t424634  AST-N808  \t424711  AST-N810 \t424712  AST-N811  \t424713  AST-N813  \t424722  AST-N815  \t425054  AST-XN09  \t423425  AST-XN15  \t423829  AST-XN17  \t423673  AST-XN18  \t423874  AST-XN20  \t423947  AST-XN21  \t424197  AST-XN22  \t424199  AST-XN23  \t424198  AST-XN24  \t424351  AST-XN26  \t424500  AST-XN28  \t424586  AST-XN29 \t424604  AST-XN30  \t424639  AST-XN31 \t424640  AST-XN32  \t424678  AST-XN33  \t424723  AST-XN34  \t424752  AST-XN35  \t424810  AST-XN36  \t424860  AST-XN37  \t424888  AST-XN38  \t425074  AST-XN39  \t425086  AST-XN40  \t425095  AST-XN41  \t425204  AST-XN42 \t425309   ***Update 4/2/26 -- Additional product references not manufactured at time of initial notification. These products will not be distributed within the United States.***  AST-N484 Ref. 425181 AST-N486 Ref. 425183 AST-N491 Ref. 425206 AST-N494 Ref. 425224 AST-N485 Ref. 425182 AST-XN41 Ref. 425204 AST-XN42 Ref. 425309 AST-N504 Ref. 425491",
  "description": "FDA recall Z-1236-2026 — Biomerieux Inc is recalling VITEK 2 Gram-negative Susceptibility Cards Containing o\tPolymyxin B (pb02n) o\tCeftazidime/avibactam (cza02n) o\tMeropenem/Vaborbactam (mev01n) o\tImipenem (ipm05n) o\tImipenem/Relebactam (ipr01n);  CARD NAME/ PRODUCT REFERENCE:  AST-N399  \t423701  AST-N402  \t423644  AST-N403  \t423645  AST-N404  \t423664  AST-N405  \t423864  AST-N406  \t423869  AST-N407  \t423870  AST-N409  \t423925  AST-N412  \t423936  AST-N413  \t423928  AST-N414  \t423933  AST-N415  \t423934  AST-N416  \t423935  AST-N417  \t423880  AST-N419  \t423948  AST-N421  \t424055  AST-N428  \t424320  AST-N429  \t424321  AST-N430  \t424322  AST-N433  \t424389  AST-N439  \t424501  AST-N440  \t424502  AST-N443  \t424541  AST-N444  \t424587  AST-N467  \t424857  AST-N476  \t424934  AST-N478  \t425052  AST-N480 \t425084  AST-N481  \t425085  AST-N485 \t425182  AST-N496 \t425265  AST-N800  \t423310  AST-N802  \t423706  AST-N804  \t424634  AST-N808  \t424711  AST-N810 \t424712  AST-N811  \t424713  AST-N813  \t424722  AST-N815  \t425054  AST-XN09  \t423425  AST-XN15  \t423829  AST-XN17  \t423673  AST-XN18  \t423874  AST-XN20  \t423947  AST-XN21  \t424197  AST-XN22  \t424199  AST-XN23  \t424198  AST-XN24  \t424351  AST-XN26  \t424500  AST-XN28  \t424586  AST-XN29 \t424604  AST-XN30  \t424639  AST-XN31 \t424640  AST-XN32  \t424678  AST-XN33  \t424723  AST-XN34  \t424752  AST-XN35  \t424810  AST-XN36  \t424860  AST-XN37  \t424888  AST-XN38  \t425074  AST-XN39  \t425086  AST-XN40  \t425095  AST-XN41  \t425204  AST-XN42 \t425309   ***Update 4/2/26 -- Additional product references not manufactured at time of initial notification. These products will not be distributed within the United States.***  AST-N484 Ref. 425181 AST-N486 Ref. 425183 AST-N491 Ref. 425206 AST-N494 Ref. 425224 AST-N485 Ref. 425182 AST-XN41 Ref. 425204 AST-XN42 Ref. 425309 AST-N504 Ref. 425491 (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/",
  "isAccessibleForFree": true,
  "isPartOf": "https://drug-device-safety-atlas.ryanjhunter.workers.dev/",
  "rdfs:isDefinedBy": "https://drug-device-safety-atlas.ryanjhunter.workers.dev/vocab/agent-native",
  "seeAlso": "https://agenticu.ryanjhunter.workers.dev/commons/the-research-object",
  "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": {
      "@type": "schema:GovernmentOrganization",
      "name": "U.S. Food & Drug Administration"
    }
  },
  "sameAs": "https://www.accessdata.fda.gov/scripts/enforcement/enforce_rpt-Product-Tabs.cfm?action=select&recall_number=Z-1236-2026&lang=eng",
  "about": {
    "@type": "schema:MedicalDevice",
    "name": "VITEK 2 Gram-negative Susceptibility Cards Containing o\tPolymyxin B (pb02n) o\tCeftazidime/avibactam (cza02n) o\tMeropenem/Vaborbactam (mev01n) o\tImipenem (ipm05n) o\tImipenem/Relebactam (ipr01n);  CARD NAME/ PRODUCT REFERENCE:  AST-N399  \t423701  AST-N402  \t423644  AST-N403  \t423645  AST-N404  \t423664  AST-N405  \t423864  AST-N406  \t423869  AST-N407  \t423870  AST-N409  \t423925  AST-N412  \t423936  AST-N413  \t423928  AST-N414  \t423933  AST-N415  \t423934  AST-N416  \t423935  AST-N417  \t423880  AST-N419  \t423948  AST-N421  \t424055  AST-N428  \t424320  AST-N429  \t424321  AST-N430  \t424322  AST-N433  \t424389  AST-N439  \t424501  AST-N440  \t424502  AST-N443  \t424541  AST-N444  \t424587  AST-N467  \t424857  AST-N476  \t424934  AST-N478  \t425052  AST-N480 \t425084  AST-N481  \t425085  AST-N485 \t425182  AST-N496 \t425265  AST-N800  \t423310  AST-N802  \t423706  AST-N804  \t424634  AST-N808  \t424711  AST-N810 \t424712  AST-N811  \t424713  AST-N813  \t424722  AST-N815  \t425054  AST-XN09  \t423425  AST-XN15  \t423829  AST-XN17  \t423673  AST-XN18  \t423874  AST-XN20  \t423947  AST-XN21  \t424197  AST-XN22  \t424199  AST-XN23  \t424198  AST-XN24  \t424351  AST-XN26  \t424500  AST-XN28  \t424586  AST-XN29 \t424604  AST-XN30  \t424639  AST-XN31 \t424640  AST-XN32  \t424678  AST-XN33  \t424723  AST-XN34  \t424752  AST-XN35  \t424810  AST-XN36  \t424860  AST-XN37  \t424888  AST-XN38  \t425074  AST-XN39  \t425086  AST-XN40  \t425095  AST-XN41  \t425204  AST-XN42 \t425309   ***Update 4/2/26 -- Additional product references not manufactured at time of initial notification. These products will not be distributed within the United States.***  AST-N484 Ref. 425181 AST-N486 Ref. 425183 AST-N491 Ref. 425206 AST-N494 Ref. 425224 AST-N485 Ref. 425182 AST-XN41 Ref. 425204 AST-XN42 Ref. 425309 AST-N504 Ref. 425491",
    "manufacturer": {
      "@type": "schema:Organization",
      "name": "Biomerieux Inc"
    }
  },
  "claims": [
    {
      "@id": "https://drug-device-safety-atlas.ryanjhunter.workers.dev/recalls/Z-1236-2026/enforcement-record",
      "@type": "schema:Claim",
      "name": "FDA recall Z-1236-2026: Biomerieux Inc is recalling VITEK 2 Gram-negative Susceptibility Cards Containing o\tPolymyxin B (pb02n) o\tCeftazidime/avibactam (cza02n) o\tMeropenem/Vaborbactam (mev01n) o\tImipenem (ipm05n) o\tImipenem/Relebactam (ipr01n);  CARD NAME/ PRODUCT REFERENCE:  AST-N399  \t423701  AST-N402  \t423644  AST-N403  \t423645  AST-N404  \t423664  AST-N405  \t423864  AST-N406  \t423869  AST-N407  \t423870  AST-N409  \t423925  AST-N412  \t423936  AST-N413  \t423928  AST-N414  \t423933  AST-N415  \t423934  AST-N416  \t423935  AST-N417  \t423880  AST-N419  \t423948  AST-N421  \t424055  AST-N428  \t424320  AST-N429  \t424321  AST-N430  \t424322  AST-N433  \t424389  AST-N439  \t424501  AST-N440  \t424502  AST-N443  \t424541  AST-N444  \t424587  AST-N467  \t424857  AST-N476  \t424934  AST-N478  \t425052  AST-N480 \t425084  AST-N481  \t425085  AST-N485 \t425182  AST-N496 \t425265  AST-N800  \t423310  AST-N802  \t423706  AST-N804  \t424634  AST-N808  \t424711  AST-N810 \t424712  AST-N811  \t424713  AST-N813  \t424722  AST-N815  \t425054  AST-XN09  \t423425  AST-XN15  \t423829  AST-XN17  \t423673  AST-XN18  \t423874  AST-XN20  \t423947  AST-XN21  \t424197  AST-XN22  \t424199  AST-XN23  \t424198  AST-XN24  \t424351  AST-XN26  \t424500  AST-XN28  \t424586  AST-XN29 \t424604  AST-XN30  \t424639  AST-XN31 \t424640  AST-XN32  \t424678  AST-XN33  \t424723  AST-XN34  \t424752  AST-XN35  \t424810  AST-XN36  \t424860  AST-XN37  \t424888  AST-XN38  \t425074  AST-XN39  \t425086  AST-XN40  \t425095  AST-XN41  \t425204  AST-XN42 \t425309   ***Update 4/2/26 -- Additional product references not manufactured at time of initial notification. These products will not be distributed within the United States.***  AST-N484 Ref. 425181 AST-N486 Ref. 425183 AST-N491 Ref. 425206 AST-N494 Ref. 425224 AST-N485 Ref. 425182 AST-XN41 Ref. 425204 AST-XN42 Ref. 425309 AST-N504 Ref. 425491",
      "text": "The FDA logged enforcement record Z-1236-2026: Biomerieux Inc is voluntarily recalling VITEK 2 Gram-negative Susceptibility Cards Containing o\tPolymyxin B (pb02n) o\tCeftazidime/avibactam (cza02n) o\tMeropenem/Vaborbactam (mev01n) o\tImipenem (ipm05n) o\tImipenem/Relebactam (ipr01n);  CARD NAME/ PRODUCT REFERENCE:  AST-N399  \t423701  AST-N402  \t423644  AST-N403  \t423645  AST-N404  \t423664  AST-N405  \t423864  AST-N406  \t423869  AST-N407  \t423870  AST-N409  \t423925  AST-N412  \t423936  AST-N413  \t423928  AST-N414  \t423933  AST-N415  \t423934  AST-N416  \t423935  AST-N417  \t423880  AST-N419  \t423948  AST-N421  \t424055  AST-N428  \t424320  AST-N429  \t424321  AST-N430  \t424322  AST-N433  \t424389  AST-N439  \t424501  AST-N440  \t424502  AST-N443  \t424541  AST-N444  \t424587  AST-N467  \t424857  AST-N476  \t424934  AST-N478  \t425052  AST-N480 \t425084  AST-N481  \t425085  AST-N485 \t425182  AST-N496 \t425265  AST-N800  \t423310  AST-N802  \t423706  AST-N804  \t424634  AST-N808  \t424711  AST-N810 \t424712  AST-N811  \t424713  AST-N813  \t424722  AST-N815  \t425054  AST-XN09  \t423425  AST-XN15  \t423829  AST-XN17  \t423673  AST-XN18  \t423874  AST-XN20  \t423947  AST-XN21  \t424197  AST-XN22  \t424199  AST-XN23  \t424198  AST-XN24  \t424351  AST-XN26  \t424500  AST-XN28  \t424586  AST-XN29 \t424604  AST-XN30  \t424639  AST-XN31 \t424640  AST-XN32  \t424678  AST-XN33  \t424723  AST-XN34  \t424752  AST-XN35  \t424810  AST-XN36  \t424860  AST-XN37  \t424888  AST-XN38  \t425074  AST-XN39  \t425086  AST-XN40  \t425095  AST-XN41  \t425204  AST-XN42 \t425309   ***Update 4/2/26 -- Additional product references not manufactured at time of initial notification. These products will not be distributed within the United States.***  AST-N484 Ref. 425181 AST-N486 Ref. 425183 AST-N491 Ref. 425206 AST-N494 Ref. 425224 AST-N485 Ref. 425182 AST-XN41 Ref. 425204 AST-XN42 Ref. 425309 AST-N504 Ref. 425491 — reason: Potential risk of Quality Control failures and/or false resistant antibiotic results when testing isolates of Enterobacterales/Enterobacteriaceae species and/or Pseudomonas aeruginosa with the identified antibiotic formulations. Issue may lead to QC failure or false resistant results.. Status: Ongoing — the recall is still being carried out.. Initiated 2026-01-05. Affected lots/codes: All lot codes of the identified Gram-negative AST test kits.. 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-1236-2026&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-1236-2026&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-1236-2026/fda-classification",
      "@type": "schema:Claim",
      "name": "FDA classified recall Z-1236-2026 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
      },
      "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-1236-2026&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-1236-2026&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-1236-2026/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."
    }
  ],
  "hasPart": [
    {
      "@type": "schema:ItemList",
      "name": "FDA recall details — Z-1236-2026",
      "numberOfItems": 9,
      "itemListElement": [
        {
          "@type": "schema:ListItem",
          "position": 1,
          "item": {
            "Field": "Recall number",
            "Value": "Z-1236-2026",
            "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 II",
            "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": "Biomerieux Inc",
            "Status": "recorded"
          }
        },
        {
          "@type": "schema:ListItem",
          "position": 6,
          "item": {
            "Field": "Reason",
            "Value": "Potential risk of Quality Control failures and/or false resistant antibiotic results when testing isolates of Enterobacterales/Enterobacteriaceae species and/or Pseudomonas aeruginosa with the identified antibiotic formulations. Issue may lead to QC failure or false resistant results.",
            "Status": "recorded"
          }
        },
        {
          "@type": "schema:ListItem",
          "position": 7,
          "item": {
            "Field": "Initiated",
            "Value": "2026-01-05",
            "Status": "recorded"
          }
        },
        {
          "@type": "schema:ListItem",
          "position": 8,
          "item": {
            "Field": "Lot/code info",
            "Value": "All lot codes of the identified Gram-negative AST test kits.",
            "Status": "recorded"
          }
        },
        {
          "@type": "schema:ListItem",
          "position": 9,
          "item": {
            "Field": "Distribution pattern",
            "Value": "Worldwide - US Nationwide distribution.",
            "Status": "recorded"
          }
        }
      ]
    }
  ]
}