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  "name": "RAPIDPoint 500 Systems Wash/Waste Cartridge (4 Pack). Material Number: 10329097.",
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      "name": "FDA recall Z-2230-2025: Siemens Healthcare Diagnostics Inc is recalling RAPIDPoint 500 Systems Wash/Waste Cartridge (4 Pack). Material Number: 10329097.",
      "text": "The FDA logged enforcement record Z-2230-2025: Siemens Healthcare Diagnostics Inc is voluntarily recalling RAPIDPoint 500 Systems Wash/Waste Cartridge (4 Pack). Material Number: 10329097. — reason: Siemens Healthcare Diagnostics is recalling the RAPIDPoint 500 Systems Wash/Waste Cartridge Lot WW/08925 due to a manufacturing error causing positive and negative bias in Ionized Calcium, Potassium, pH, Chloride, pCO2, Glucose and Lactate analytes and their derivatives. Four complaints were filed related to this event that led to Siemens Healthcare Diagnostics identifying an error in the manufacturing process and initiated corrective actions. Use of the affected device may result in errors during QC which could lead to a delay in patient treatment. If bias generated from this issue is not caught during QC erroneous results may cause temporary or medically reversible adverse health consequences to patients.. Status: Ongoing — the recall is still being carried out.. Initiated 2025-06-26. Affected lots/codes: Material Number: 10329097. GTIN Number: 00630414482163. Lot Number: WW/08925. Expiration Date: 12/03/2025.. A RECORDED FDA enforcement action (occurred=true).",
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      "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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      "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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