Siemens RAPIDPoint 500 Lactate Cartridges Recalled for Electrolyte Error Codes
Siemens Healthcare Diagnostics Inc is recalling RAPIDPoint 500 Lactate Cartridges because they may display error codes for electrolyte parameters.
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: The recall is classified as FDA Class II, which typically indicates a reasonable probability of temporary or medically reversible health consequences. The hazard involves potential diagnostic errors regarding electrolyte parameters, which is a significant risk of harm where injury has not yet been reported.
Plain-English summary
Siemens Healthcare Diagnostics Inc is recalling the RAPIDPoint 500 Measurement Cartridge Lactate in various pack sizes (100, 250, 400, and 750 tests). The recall involves 20,507 cartridges with serial numbers ranging from 2334500011 through 2412705915. These products were distributed nationwide and in numerous foreign countries.
The recall was initiated because the RAPIDPoint 500 Measurement Cartridges may have an error code for one or more electrolyte parameters, such as sodium (Na+), calcium (Ca++), potassium (K+), or chloride (Cl-). This issue is classified as an FDA Class II recall.
Healthcare facilities and consumers should stop using the affected cartridges and contact Siemens Healthcare Diagnostics Inc for further instructions or a replacement.
The recalled product
- Product
- RAPIDPoint 500 Measurement Clinical Chemistry System RAPIDPoint 500 Measurement Cartridge Lactate (750 Tests) Part number: 10491449; RAPIDPoint 500 Measurement Cartridge Lactate (400 Tests) Part Number: 10491448 RAPIDPoint 500 Measurement Cartridge Lactate (250 Tests) Part…
- Manufacturer
- Siemens Healthcare Diagnostics Inc
- Affected units
- 20,507
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)
- Serial Numbers: 2334500011 through 2412705915
Distribution
Distributed nationwide across the United States.
Related recalls
Same manufacturer · Siemens Healthcare Diagnostics Inc
See all →- HighSiemens Atellica CH C-Reactive Protein Reagent Recalled for Falsely Elevated Results
FDA (Devices) · 2026-10-07
- SevereSiemens Recalls Emit 2000 Quinidine Assay Due to Precision Issues
FDA (Devices) · 2026-08-26
- SevereSiemens Quinidine Assay Recalled for Precision Errors
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
Same hazard · diagnostic error
See all →- ModeratePhilips Ingenia MRI Systems Recalled for Incorrect DTI Data Exports
FDA (Devices) · 2026-10-07
- HighSiemens Immulite 2000 Syphilis Screen Recall for Negative Bias
FDA (Devices) · 2026-08-26
- HighSiemens Immulite 2000 Syphilis Screen Recalled for Negative Bias
FDA (Devices) · 2026-08-26
- HighPhilips CT Scanners Recalled Due to Bolus Tracking Trigger Issue
FDA (Devices) · 2026-08-05
- HighPhilips IQon Spectral CT Recalled Due to Automatic Scan Trigger Failure
FDA (Devices) · 2026-08-05
Similar recalls
- HighSiemens RAPIDPoint 500 Lactate Cartridges Recalled for Sodium Bias
FDA (Devices) · 2015-09-30
- HighRAPIDPoint 500 Measurement Cartridges Recalled for Sodium Sensor Bias
FDA (Devices) · 2023-12-27
- HighRAPIDPoint 500 Diagnostic Cartridges Recall Due to Sodium Sensor Measurement Bias
FDA (Devices) · 2023-12-27
- HighRAPIDPoint 500 Measurement Cartridge Sodium Sensor Negative Bias Risk
FDA (Devices) · 2023-12-27
- HighRAPIDPoint 500 wash waste cartridge lot biases seven blood analytes
FDA (Devices) · 2025-08-06
- HighRAPIDPoint 500 Measurement Cartridge Sodium Sensor May Cause Measurement Error
FDA (Devices) · 2023-12-27