—#214845

Product

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

FDA product code: CHL — Electrode Measurement, Blood-Gases (Pco2, Po2) And Blood Ph
Device class: Class 2
Medical specialty: Clinical Chemistry
510(k) numbers: K002738
Affected lot / code info: Material Number: 10329097. GTIN Number: 00630414482163. Lot Number: WW/08925. Expiration Date: 12/03/2025.

Why it was recalled

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.

Root cause (FDA determination)

Under Investigation by firm

Action the firm took

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.

Recalling firm

Firm: Siemens Healthcare Diagnostics Inc
Address: 2 Edgewater Dr, Norwood, Massachusetts 02062-4637

Distribution

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

Timeline

Recall initiated: 2025-06-26
Posted by FDA: 2025-07-31
Status: —

Source: openFDA Device Recall endpoint. Recall record ID #214845. The FDA issues recall classifications as health-hazard assessments, not legal findings; for legal claims consult a licensed attorney.