# FDA recall Z-2230-2025

> **Siemens Healthcare Diagnostics Inc** · Class II · device recall initiated 2025-06-26.

## Product

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

## 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.

## Key facts

- **Recall number:** Z-2230-2025
- **Recalling firm:** Siemens Healthcare Diagnostics Inc
- **Classification:** Class II
- **Product type:** device
- **Status:** Ongoing
- **Initiation date:** 2025-06-26
- **Report date:** 2025-08-06

- **Voluntary/Mandated:** Voluntary: Firm initiated
- **Location:** Norwood, MA, United States

## Primary source

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

## Citation

> AI Analytics. FDA recall Z-2230-2025. Retrieved 2026-07-16 from https://api.ai-analytics.org/recall/Z-2230-2025. Source: US FDA. Licensed CC0.

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