Medical Device Recall: RAPIDPoint 500 Systems Wash/Waste Cartridge (4 Pack). Material Number: 10329097.
Siemens Healthcare Diagnostics Inc · June 26, 2025
Reason for Recall
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.
Distribution
worldwide distribution - US Nationwide and the countries of Canada, Chile, Japan, Paraguay.
States Affected
NATIONWIDE
Quantity Affected
1,477 units
Source: FDA (openFDA Device Enforcement)
Recall number: Z-2230-2025
Status: ongoing
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