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  "@id": "https://drug-device-safety-atlas.ryanjhunter.workers.dev/recalls/Z-1040-2024.jsonld",
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  "name": "BD BBL Sensi Disc Tetracycline 30 ug,used for semi-quantitative in vitro susceptibility testing. Catalog Number 230998 and 231344¿",
  "description": "FDA recall Z-1040-2024 — Becton Dickinson & Co. is recalling BD BBL Sensi Disc Tetracycline 30 ug,used for semi-quantitative in vitro susceptibility testing. Catalog Number 230998 and 231344¿ (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.",
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  "dateModified": "2026-06-24T07:02:03.626072+00:00",
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    "name": "BD BBL Sensi Disc Tetracycline 30 ug,used for semi-quantitative in vitro susceptibility testing. Catalog Number 230998 and 231344¿",
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      "name": "Becton Dickinson & Co."
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      "name": "FDA recall Z-1040-2024: Becton Dickinson & Co. is recalling BD BBL Sensi Disc Tetracycline 30 ug,used for semi-quantitative in vitro susceptibility testing. Catalog Number 230998 and 231344¿",
      "text": "The FDA logged enforcement record Z-1040-2024: Becton Dickinson & Co. is voluntarily recalling BD BBL Sensi Disc Tetracycline 30 ug,used for semi-quantitative in vitro susceptibility testing. Catalog Number 230998 and 231344¿ — reason: There is a possibility of reproducibility, accuracy, and/or QC failures in antibiotic susceptibility testing (AST) for H. influenzae. This may cause product discard, delayed results, or additional adverse diagnostic outcomes, such as a delay in diagnosis, the selection of inappropriate antibiotics, or extended duration of antibiotic exposure and the treatment process.. Status: Ongoing — the recall is still being carried out.. Initiated 2024-01-08. Affected lots/codes: Catalog No. 230998 UDI-DI 00382902309987 Lots 1242880 1277918 1301570 2025088 2056233 2118569 2276681 3094187 3212760 3263267 9009914 9046895 0065366 0178210;  Catalog No. 231344¿ UDI-DI 30382902313442 Lots 3010027 3062263 3094187 3158029 3212760 3263267 3275644 0065366 0085202 0230453 0274792 0335906 1095603 1148539 1180271 1242880 1277918 1301570 2025088 2056233 2089874 2118569 2276681 8355562 9009914 9046895 9130797 9239639 9263061. A RECORDED FDA enforcement action (occurred=true).",
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        "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-1040-2024&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."
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      "@id": "https://drug-device-safety-atlas.ryanjhunter.workers.dev/recalls/Z-1040-2024/fda-classification",
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      "name": "FDA classified recall Z-1040-2024 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.",
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      "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-1040-2024/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.",
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      },
      "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": "Reason",
            "Value": "There is a possibility of reproducibility, accuracy, and/or QC failures in antibiotic susceptibility testing (AST) for H. influenzae. This may cause product discard, delayed results, or additional adverse diagnostic outcomes, such as a delay in diagnosis, the selection of inappropriate antibiotics, or extended duration of antibiotic exposure and the treatment process.",
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