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  "name": "epoc BGEM BUN Test Card (25 pk) for the epoc Blood Analysis System, SMN 10736515",
  "description": "FDA recall Z-0286-2025 — Siemens Healthcare Diagnostics Inc is recalling epoc BGEM BUN Test Card (25 pk) for the epoc Blood Analysis System, SMN 10736515 (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": "epoc BGEM BUN Test Card (25 pk) for the epoc Blood Analysis System, SMN 10736515",
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      "name": "FDA recall Z-0286-2025: Siemens Healthcare Diagnostics Inc is recalling epoc BGEM BUN Test Card (25 pk) for the epoc Blood Analysis System, SMN 10736515",
      "text": "The FDA logged enforcement record Z-0286-2025: Siemens Healthcare Diagnostics Inc is voluntarily recalling epoc BGEM BUN Test Card (25 pk) for the epoc Blood Analysis System, SMN 10736515 — reason: Siemens Healthcare Diagnostics Inc. has confirmed that a negative sodium bias may exist in one lot of epoc BGEM BUN Test Cards approximately 2 months prior to expiration. The observed maximum negative bias from internal testing is -10 mmol/L. No positive bias has been observed. Quality Control (QC) fluid may or may not detect the issue depending on the bias magnitude and the frequency of QC testing.    One customer complaint has been associated with this issue. No adverse events have been reported.    All affected lots have recently expired before the issuance of the recall.. Status: Ongoing — the recall is still being carried out.. Initiated 2024-09-24. Affected lots/codes: UDI-DI: 00809708121860; Lot Numbers: 08-24092-60 08-24093-60 08-24094-60 08-24095-60 08-24096-60. A RECORDED FDA enforcement action (occurred=true).",
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      "name": "FDA classified recall Z-0286-2025 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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      "@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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            "Value": "Siemens Healthcare Diagnostics Inc. has confirmed that a negative sodium bias may exist in one lot of epoc BGEM BUN Test Cards approximately 2 months prior to expiration. The observed maximum negative bias from internal testing is -10 mmol/L. No positive bias has been observed. Quality Control (QC) fluid may or may not detect the issue depending on the bias magnitude and the frequency of QC testing.    One customer complaint has been associated with this issue. No adverse events have been reported.    All affected lots have recently expired before the issuance of the recall.",
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