FDA-Device2025-08-06Class II

RAPIDPoint 500 Systems Wash/Waste Cartridge (4 Pack). Material Number: 10329097.

Siemens Healthcare Diagnostics Inc

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.

Sold states

worldwide distribution - US Nationwide and the countries of Canada, Chile, Japan, Paraguay.

Affected count

1,477 units

Manufactured in

2 Edgewater Dr, Norwood, MA, United States

Products

RAPIDPoint 500 Systems Wash/Waste Cartridge (4 Pack). Material Number: 10329097.

Official notice

https://www.accessdata.fda.gov/scripts/ires/index.cfm?Product=Z-2230-2025

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