RAPIDPoint 500 Measurement Cartridge Sodium Sensor Negative Bias Risk
Siemens RAPIDPoint 500 measurement cartridges may produce inaccurate sodium readings, risking delayed diagnosis of dangerous electrolyte imbalances or unnecessary treatment.
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 medical device recall with potential for serious harm from measurement errors causing delayed or incorrect diagnosis of critical electrolyte imbalances. No illnesses or injuries have been reported; the hazard is potential rather than realized.
Plain-English summary
Siemens Healthcare Diagnostics Inc is recalling RAPIDPoint 500 measurement cartridges (with lactate). Approximately 3,505 cartridges were distributed in the United States with additional worldwide distribution.
The sodium sensor in affected cartridges can produce a negative bias in measurement results. This could result in serious injury through delayed diagnosis of hypernatremia (high sodium), unnecessary treatment for hyponatremia (low sodium), or iatrogenic hypernatremia—especially when true sodium values are near critical thresholds.
The cartridges may also generate a Question Result error flag for multiple electrolyte measurements on patient and quality control samples, potentially causing delays in diagnosis or treatment.
The recalled product
- Product
- RAPIDPoint 500 Systems Measurement Cartridge (with Lactate) 750-Intended for in vitro diagnostic use and is designed to provide the determination in whole blood. SMN: 10491449
- Manufacturer
- Siemens Healthcare Diagnostics Inc
- Category
- Medical Device
- Hazard
- measurement-error
- delayed-diagnosis
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: 00630414589770 All serial numbers
Distribution
Distributed nationwide across the United States.
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