RAPIDPoint 500 Diagnostic Cartridges Recall Due to Sodium Sensor Measurement Bias
Siemens is recalling RAPIDPoint 500 measurement cartridges because the sodium sensor can produce inaccurate readings, potentially leading to delayed diagnosis or incorrect treatment of electrolyte imbalances.
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 with potential for serious patient harm through measurement error affecting critical diagnostic values, meeting the criterion for 'risk-of-harm products where injury has not yet been reported.' No illnesses or injuries have been documented in the source material.
Plain-English summary
Siemens Healthcare Diagnostics Inc is recalling RAPIDPoint 500 Systems Measurement Cartridges (with Lactate) due to a defect in the sodium (Na+) sensor. The sensor can produce measurements with a negative bias, resulting in readings lower than the patient's actual sodium level.
This measurement error can cause serious patient harm when true sodium levels are near critical thresholds. The negative bias may delay diagnosis of dangerously high sodium levels (hypernatremia) if the faulty reading appears normal. Conversely, when sodium levels are actually low or normal, the false reading may trigger unnecessary treatment for hyponatremia. If patients are treated for this false hyponatremia with sodium supplementation, they may develop iatrogenic hypernatremia—dangerously high sodium levels caused by the treatment itself. Additionally, the cartridge may display a 'Question Result' error flag for multiple electrolytes, which can further delay proper diagnosis and treatment.
A total of 6035 cartridges have been distributed in the United States, with additional units distributed to numerous countries worldwide. All serial numbers of the affected product are included in this recall.
The recalled product
- Product
- RAPIDPoint 500 Systems Measurement Cartridge (with Lactate) 250-Intended for in vitro diagnostic use and is designed to provide the determination in whole blood. SMN: 10491447
- Manufacturer
- Siemens Healthcare Diagnostics Inc
- Hazard
- sensor-bias
- delayed-diagnosis
- electrolyte-imbalance
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: 00630414589756 All serial numbers
Distribution
Distributed nationwide across the United States.
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