RAPIDPoint 500 Measurement Cartridge Sodium Sensor May Cause Measurement Error
Siemens RAPIDPoint 500 cartridges may produce inaccurate sodium measurements in blood samples, potentially delaying diagnosis or causing inappropriate treatment. The sodium sensor may show a negative bias, affecting patient care.
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: FDA Class II recall of a diagnostic device with a sensor defect that could produce measurement errors, potentially leading to delayed diagnosis or inappropriate treatment. No illnesses or injuries have been reported; under the rubric, risk-of-harm products where injury has not yet been reported score at most 3 (High).
Plain-English summary
Siemens Healthcare Diagnostics has recalled RAPIDPoint 500 Systems Measurement Cartridges (with Lactate) 400 due to a potential defect in the sodium (Na+) sensor. These are in-vitro diagnostic devices designed to measure sodium levels in whole blood samples.
The sodium sensor may produce a negative bias in measurements. This could result in delayed diagnosis of high sodium levels (hypernatremia) or unnecessary treatment for low sodium levels (hyponatremia). In cases where the true sodium result is near critical thresholds, the measurement error could lead to serious clinical consequences, including treatment-induced high sodium levels (iatrogenic hypernatremia). Additionally, the defect may cause error flags for multiple electrolyte readings that could delay diagnosis or treatment.
The recalled cartridges were distributed nationwide and to multiple countries worldwide. Approximately 6,611 cartridges were distributed in the United States. The recall affects laboratory facilities and hospitals using these cartridges for patient blood sodium testing.
The recalled product
- Product
- RAPIDPoint 500 Systems Measurement Cartridge (with Lactate) 400-Intended for in vitro diagnostic use and is designed to provide the determination in whole blood. SMN: 10491448
- Manufacturer
- Siemens Healthcare Diagnostics Inc
- Hazard
- measurement-bias
- delayed-diagnosis
- treatment-error
Is your product affected?
Check your packaging against the codes below. If any of them match, the product is part of this recall.
Lot numbers (1)
- UDI-DI: 00630414589763 All serial numbers
Distribution
Distributed nationwide across the United States.
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