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  "name": "Xpert Xpress Strep A,  XPRSTREPA-10, P/N: 302-2294 IVD, Rx Only",
  "description": "FDA recall Z-0215-2024 — Cepheid is recalling Xpert Xpress Strep A,  XPRSTREPA-10, P/N: 302-2294 IVD, Rx Only (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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    "name": "Xpert Xpress Strep A,  XPRSTREPA-10, P/N: 302-2294 IVD, Rx Only",
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      "name": "FDA recall Z-0215-2024: Cepheid is recalling Xpert Xpress Strep A,  XPRSTREPA-10, P/N: 302-2294 IVD, Rx Only",
      "text": "The FDA logged enforcement record Z-0215-2024: Cepheid is voluntarily recalling Xpert Xpress Strep A,  XPRSTREPA-10, P/N: 302-2294 IVD, Rx Only — reason: pipettes packaged in Strep A test may fail to dispense an adequate sample volume which could result in \"invalid\" results or no result test  results.. Status: Ongoing — the recall is still being carried out.. Initiated 2023-04-24. Affected lots/codes: UDI: (01)07332940006372/ Lots:     23718 23719 23720 10309 23201 23305 23308 23312 23314 23315 23401 23402 23403 23404 23405 23406 23407 23501 23504 23505 23506 23408 23410 23510 23411 23604 23605 23607 23608 23609 23610 23611 23612 23701 23702 23703 23705 23706 23707 23708 23709 23710 23711 23712 23714 23716 23717 23113 23316 23912 24112 23820 24704 24302 24307 24507 24508 24511 23822 23823 23824 24512 24513 24514 23825 24313 24515 24516 24517 24805. A RECORDED FDA enforcement action (occurred=true).",
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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RECORD of measured/reported events (occurred=true) from openFDA drug & device enforcement (recall) reports — U.S. FDA; superseded when openFDA drug & device enforcement (recall) reports — U.S. FDA publishes its next release."
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      "name": "FDA classified recall Z-0215-2024 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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    {
      "@id": "https://drug-device-safety-atlas.ryanjhunter.workers.dev/recalls/Z-0215-2024/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": "pipettes packaged in Strep A test may fail to dispense an adequate sample volume which could result in \"invalid\" results or no result test  results.",
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