FDA Recalls RAPIDPoint 500 Wash/Waste Cartridge for Inaccurate Test Results
Siemens recalls RAPIDPoint 500 wash/waste cartridges due to manufacturing errors that may cause inaccurate blood test results in clinical laboratories.
What this means for you
Real risk of harm even if no illness or injury has been reported yet. Stop using the product and follow the agency's guidance.
Our severity reasoning: This FDA Class II recall involves a manufacturing defect capable of producing inaccurate diagnostic test results with potential for patient harm, though no illnesses or injuries are documented. The rubric applies: risk-of-harm products where injury has not yet been reported.
Plain-English summary
Siemens Healthcare Diagnostics is recalling RAPIDPoint 500 Systems Wash/Waste Cartridges (Lot WW/08925) due to a manufacturing error that can cause inaccurate test results. The affected cartridges may produce biased measurements for ionized calcium, potassium, pH, chloride, pCO2, glucose, and lactate.
Medical laboratories using these cartridges may not detect errors during quality control testing, potentially leading to delayed patient diagnosis and treatment. If the testing bias is not identified, results may be temporarily inaccurate or cause medically reversible adverse health consequences to patients.
Approximately 1,477 units have been distributed worldwide, including the United States, Canada, Chile, Japan, and Paraguay. Siemens initiated the recall after four complaints related to the manufacturing error were filed.
Healthcare facilities that received cartridges from Lot WW/08925 (Material Number 10329097) should discontinue use and contact Siemens Healthcare Diagnostics for replacements.
The recalled product
- Product
- RAPIDPoint 500 Systems Wash/Waste Cartridge (4 Pack). Material Number: 10329097.
- Manufacturer
- Siemens Healthcare Diagnostics Inc
- Hazard
- manufacturing-defect
- test-result-inaccuracy
- diagnostic-error
Distribution
Distributed nationwide across the United States.
Related recalls
Same category
- SevereMedline spinal anesthesia kits recalled for bupivacaine quality issues
FDA (Devices) · 2026-06-03
- SevereMedline Spinal Trays Recalled Due to Quality and Efficacy Concerns
FDA (Devices) · 2026-06-03
- SevereMedline Spinal Block Kits Recalled for Data Integrity and Efficacy Issues
FDA (Devices) · 2026-06-03
- SevereAbiomed Automated Impella Controller recalled for motor control and pump failure risks
FDA (Devices) · 2026-06-03
- HighGE APEXPRO and CARESCAPE Telemetry Systems Risk Loss of Patient Monitoring
FDA (Devices) · 2026-06-03