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.
The agency’s classification
FDA (Devices): Class II
Class II is a situation in which use of or exposure to a violative product may cause temporary or medically reversible adverse health consequences, or where the probability of serious adverse health consequences is remote.
This is the agency’s own classification, taken from its notice. The severity score below is our assessment, not the agency’s. How recall classes work
What this means for you
Our assessment, not the agency’s: severity 3/5 (High).
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
- Affected units
- 3,505
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
Part of a larger recall action
This product is one of 4 recalled by Siemens Healthcare Diagnostics Inc under a single FDA (Devices) recall action. The agency files each product separately, so the size of the action is not visible from this page alone.
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