RAPIDPoint 500 Systems Wash/Waste Cartridge recall
RAPIDPoint 500 Systems Wash/Waste Cartridge (4 Pack). Material Number: 10329097.
Why was RAPIDPoint 500 Systems Wash/Waste Cartridge 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.
What should I do if I have this product?
The recall is ongoing. Follow the firm and FDA instructions.
What to do with a recalled product: refunds, receipts, safe disposal and how to report a problem.
Is my product affected?
Compare the item in your hand with every identifier below from the official FDA record. Only products that match the listed product and lot, UPC or model codes are part of this recall.
Which lot codes, UPCs or models are affected?
Material Number: 10329097. GTIN Number: 00630414482163. Lot Number: WW/08925. Expiration Date: 12/03/2025.
- Product
- RAPIDPoint 500 Systems Wash/Waste Cartridge (4 Pack). Material Number: 10329097.
- Recalling firm
- Siemens Healthcare Diagnostics Inc
- Quantity
- 1,477 units
- Distribution
- worldwide distribution - US Nationwide and the countries of Canada, Chile, Japan, Paraguay.
- Recall date
- August 6, 2025
- Classification
- Class II
- Status
- Ongoing
- Agency
- FDA (device)