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Siemens Healthcare Diagnostics Inc recalls RAPIDPoint 500 Systems Wash/Waste Cartridge (4 Pack). Material Number: 10329097.

Recalled August 6, 2025 · FDA recall Z-2230-2025 · Siemens Healthcare Diagnostics

Hazard
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. · FDA Class II
Units
1,477 units
Sold at
worldwide distribution - US Nationwide and the countries of Canada, Chile, Japan, Paraguay.

Description

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.

Product
RAPIDPoint 500 Systems Wash/Waste Cartridge (4 Pack). Material Number: 10329097.
Manufacturer(s)
Siemens Healthcare Diagnostics Inc

Source: U.S. Food and Drug Administration. Official recall notice on fda.gov →

Siemens Healthcare Diagnostics Inc recalls RAPIDPoint 500 Systems Wash/Waste Cartridge (4 Pack). Material Number: 10329097. | RecallWatchUSA