RAPIDPoint 500 Systems Wash/Waste Cartridge (4 Pack). Material Number: 10329097. Recall
Issued August 6, 2025 · Siemens Healthcare Diagnostics Inc
In August 2025, Siemens Healthcare Diagnostics Inc recalled the RAPIDPoint 500 Systems Wash/Waste Cartridge (4 Pack). Material Number: 10329097., a serious health recall reported by the FDA.
Compiled by Maya Ellison, RecallCheckr
What this means for you
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.
What you should do
- 1 Stop using RAPIDPoint 500 Systems Wash/Waste Cartridge (4 Pack). Material Number: 10329097. right away.
- 2 Set it aside where it won't be used by mistake.
- 3 Contact Siemens Healthcare Diagnostics Inc to arrange your voluntary. See the official notice below for contact details.
- 4 Keep the product until your remedy is fully processed. You may need it.
Recall details
- Brand
- Siemens Healthcare Diagnostics Inc
- Category
- Health
- Recall date
- August 6, 2025
- Units affected
- Not reported
- Sold at
- worldwide distribution - US Nationwide and the countries of Canada, Chile, Japan, Paraguay.
- Recall number
- FDA-Z-2230-2025
- Made in
- United States
- Issuing agency
- FDA
In context
- Siemens Healthcare Diagnostics Inc has 2 recalls in our database.
- We're tracking 3,576 Health recalls in our database.
- This is the 691st Health recall we've logged in 2025.