Class II — Potential Health Hazard

Potential health hazard — use of or exposure to this product may cause temporary or medically reversible adverse health consequences.

RAPIDPoint 500 Systems Wash/Waste Cartridge (4 Pack). Material Number: 10329097. Recalled by Siemens Healthcare Diagnostics Inc Due to Siemens Healthcare Diagnostics is recalling the RAPIDPoint 500...

Date: June 26, 2025
Company: Siemens Healthcare Diagnostics Inc
Status: Ongoing
Source: FDA (Device)

What You Should Do

Stop using this product immediately. Do not consume, use, or distribute it.

Return the product to the place of purchase for a full refund. If you have questions, contact Siemens Healthcare Diagnostics Inc directly.

Affected Products

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

Quantity: 1,477 units

Why Was This 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.

Where Was This Sold?

This product was distributed nationwide across all 50 states.

Affected (51 states)Not affected

About Siemens Healthcare Diagnostics Inc

Siemens Healthcare Diagnostics Inc has 75 total recalls tracked by RecallDetector.

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Data sourced from the FDA (Device). Last updated March 26, 2026. View original report