RAPIDPoint 500 Wash Cartridge (Siemens) – Manufacturing Error (2025)
Hazard assessment based on recall description.
This AI-generated summary is provided for general informational purposes only and is derived from publicly available recall notices. It supplements but does not replace official agency classifications or safety instructions.
Check Your Product
According to the U.S. Food and Drug Administration (FDA)
Product
RAPIDPoint 500 Systems Wash/Waste Cartridge (4 Pack). Material Number: 10329097.
Brand
Siemens Healthcare Diagnostics Inc
Lot Codes / Batch Numbers
Not specified in FDA notice. Check official source for details.
Products Sold
Material Number: 10329097. GTIN Number: 00630414482163. Lot Number: WW/08925. Expiration Date: 12/03/2025.
Siemens Healthcare Diagnostics Inc is recalling RAPIDPoint 500 Systems Wash/Waste Cartridge (4 Pack). Material Number: 10329097. due to Siemens Healthcare Diagnostics is recalling the RAPIDPoint 500 Systems Wash/Waste Cartridge Lot WW/08925 due to a manufacturing error causing positive. Based on FDA medical device recall database.
Summary derived from FDA notice
Reason for Recall
As stated by FDA
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.
Recommended Action
Per FDA guidance
Siemens Healthcare sent an Urgent Medical Device Correction (UMDC) letter to consignees (via FedEx in the US) on around 06/26/2025. The communication letter informs consignees of the issue and provided actions for consignees to take. Consignees were instructed to review the letter with the Medical Director to determine the appropriate course of action, including for any previously generated results, if applicable, replace the both the measurement cartridge and the wash/waste cartridge if still using a wash/waste cartridge from lot WW/08925 with RAPIDPoint systems, discontinue use of the wash/waste cartridges from lot WW/08925 and dispose any remaining inventory in possession. No-cost replacement wash/waste cartridges should be made through the local Siemens Healthineers or distributor office. Consignees were also instructed to complete and return the Field Correction Effectiveness Check Form included with letter, notify customers if products were further distributed, and to retain this letter with your laboratory records and forward this letter to those who may have received this product at your site.
Verify this information on the official source
For complete details and official instructions, check the U.S. Food and Drug Administration (FDA) directly.
View official FDA recall noticePage updated: Jan 10, 2026