RAPIDPoint 500 Measurement Cartridges Recalled for Sodium Sensor Bias
Siemens is recalling RAPIDPoint 500 Systems Measurement Cartridges because the sodium sensor can develop a negative measurement bias that could delay diagnosis of serious electrolyte disorders or cause treatment errors.
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 medical device where measurement errors could cause serious patient harm through delayed diagnosis of life-threatening electrolyte disorders, though no injuries or hospitalizations are reported in the source.
Plain-English summary
Siemens Healthcare Diagnostics Inc. is recalling RAPIDPoint 500 Systems Measurement Cartridges (with Lactate), which are used in clinical laboratory settings for whole blood analysis. The cartridges are distributed nationwide and to numerous countries worldwide.
The recalled cartridges can develop a negative bias in the sodium (Na+) sensor that produces inaccurate sodium measurements. This measurement error could result in delayed diagnosis of hypernatremia (elevated blood sodium) or prompt unnecessary treatment for hyponatremia (low blood sodium). When true sodium values are near critical thresholds, such measurement errors can lead to inappropriate medical intervention and iatrogenic hypernatremia. Additionally, the device may display a "Question Result" error flag for multiple electrolyte measurements, potentially delaying patient diagnosis or treatment.
Clinical laboratories and healthcare providers should discontinue use of affected cartridges and contact Siemens for instructions on identifying recalled units and obtaining replacements.
The recalled product
- Product
- RAPIDPoint 500 Systems Measurement Cartridge (with Lactate) 100 -Intended for in vitro diagnostic use and is designed to provide the determination in whole blood. SMN: 10844813
- Manufacturer
- Siemens Healthcare Diagnostics Inc
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: 00630414947556 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.
See all 4 products in this recall →Related recalls
Same manufacturer · Siemens Healthcare Diagnostics Inc
See all →- SevereSiemens Quinidine Assay Recalled for Precision Errors
FDA (Devices) · 2026-08-26
- SevereSiemens Recalls Emit 2000 Quinidine Assay Due to Precision Issues
FDA (Devices) · 2026-08-26
- HighSiemens Atellica CH Urine Albumin In Vitro Diagnostic Recall
FDA (Devices) · 2026-08-12
- LowSyva Emit Disopyramide Enzyme Immunoassay Calibrator Recalled for Sodium Azide Concentration
FDA (Devices) · 2026-08-12
- ModerateSiemens Tricyclic Antidepressant Calibrator/Controls Recall Lot U2
FDA (Devices) · 2026-08-12
Same hazard · measurement bias
See all →- HighEmano Flow Uroflowmetry App Recalled Over Biased Flow Estimates
FDA (Devices) · 2026-07-29
- HighStago D-dimer assay shows positive bias across entire analytical range
FDA (Devices) · 2026-03-25
- HighCapillary tubes recalled over a positive bias in potassium results
FDA (Devices) · 2026-02-25
- HighVITROS Chemistry CRP Diagnostic Slides May Underreport Elevated Results
FDA (Devices) · 2024-12-04
- Highepoc BGEM BUN Test Cards recalled for sodium measurement bias
FDA (Devices) · 2024-11-13