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Recall data is sourced from official U.S. government agencies (CPSC, FDA, NHTSA, USDA) and processed using AI to improve readability. This site is not affiliated with or endorsed by any government agency. Always refer to the original agency notice for authoritative information.

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Medium RiskFDA Device
Medical Devices/Diagnostic Equipment

Siemens RAPIDPoint 500 Wash/Waste Cartridges Recalled for Testing Inaccuracies

Agency Publication Date: July 31, 2025
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Summary

Siemens Healthcare Diagnostics is recalling 1,477 units of RAPIDPoint 500 Systems Wash/Waste Cartridges (4 Pack) due to a manufacturing error. This defect can cause inaccurate test results for several blood measurements, including Ionized Calcium, Potassium, pH, Chloride, pCO2, Glucose, and Lactate. While four complaints have been filed, no specific injuries have been reported. Erroneous results could lead to a delay in patient treatment or medical decisions based on incorrect data, which may result in temporary or reversible health issues.

Risk

The affected cartridges may produce positive or negative bias in critical blood analytes, leading to incorrect diagnostic results that could cause clinicians to provide improper or delayed treatment.

What You Should Do

  1. This recall involves Siemens Healthcare Diagnostics RAPIDPoint 500 Systems Wash/Waste Cartridges (4 Pack) with Material Number 10329097, Lot Number WW/08925, and an expiration date of 12/03/2025.
  2. To identify if your supply is affected, locate the Material Number (10329097), GTIN (00630414482163), and Lot Number (WW/08925) printed on the cartridge packaging.
  3. Stop using the recalled product. Contact Siemens Healthcare Diagnostics or your medical distributor to arrange return, replacement, or correction.
  4. Call the FDA at 1-888-463-6332 (1-888-INFO-FDA) for more information or to report any adverse events related to this recall.

Your Remedy Options

๐Ÿ“‹Other Action
How to: Stop using the recalled product. Contact the manufacturer or your distributor to arrange return, replacement, or correction.

Affected Products

Product: RAPIDPoint 500 Systems Wash/Waste Cartridge (4 Pack)
Model / REF:
10329097
Lot Numbers:
WW/08925 (Exp 12/03/2025)
GTIN:
00630414482163

Quantity: 1,477 units

Additional Information

Agency: Food and Drug Administration (FDA)
Event ID: 97209
Status: Active
Manufacturer: Siemens Healthcare Diagnostics Inc
Sold By: Medical distributors; Direct sales to healthcare facilities
Manufactured In: United States
Units Affected: 1,477 units
Distributed To: Nationwide

Were You Affected by This Recall?

If you or a family member were harmed by this recalled product, you may have legal rights. Consider consulting a consumer protection attorney to understand your options for compensation.

Find an Attorney

This is general information, not legal advice. Go Backs is not a law firm and does not provide legal services.

AI-Enhanced Content: The summary, action steps, and risk assessment on this page were generated by AI from official government recall data to improve readability. This is not legal or medical advice. Always refer to the official agency sources below for authoritative information.

Sources: FDA iRES ยท Raw API Response

openFDA Disclaimer: This recall information is sourced from the openFDA API. Do not rely on openFDA to make decisions regarding medical care. While we make every effort to ensure that data is accurate, you should assume all results are unvalidated. Refer to the openFDA terms of service for more information.