Siemens RAPIDPoint 500 Blood Gas Analyzer Recalled for Neonatal Bilirubin Variability
Siemens is recalling 4,376 RAPIDPoint 500 Blood Gas Analyzers worldwide because the neonatal bilirubin parameter may show increased variability under specific high-concentration conditions.
What this means for you
Minor labeling or packaging issue, or a voluntary precautionary recall. Risk of harm is low but real — follow the manufacturer's instructions.
Our severity reasoning: The recall is classified as FDA Class II. The hazard involves increased variability in a specific test parameter under extreme conditions, which is a moderate risk to diagnostic accuracy but does not involve direct physical injury or reported illnesses.
Plain-English summary
Siemens Healthcare Diagnostics Inc is recalling 4,376 RAPIDPoint 500 Blood Gas Analyzers. The devices are distributed worldwide, including the United States, Canada, Mexico, and numerous international locations. The recall covers all serial numbers for the affected material numbers.
The recall is due to a potential issue with the neonatal bilirubin (nBili) parameter. The nBili parameter may exhibit increased variability when the nBili concentration is greater than 12 mg/dl and the total hemoglobin (tHb) concentration exceeds the upper reportable range of greater than 25 g/dl. This variability could affect the precision of the test results under these specific conditions.
The RAPIDPoint 500 system is designed for professional use in point-of-care or laboratory environments to test blood gases, electrolytes, metabolites, and hemoglobin derivatives. Users should contact Siemens Healthcare Diagnostics Inc for instructions on how to address the issue with their devices.
The recalled product
- Product
- RAPIDPoint 500 Blood Gas Analyzer; Siemens Material Number: 10492730, 10696855, 10696857, 10697306. The RAPIDPoint 500 system is designed for professional use in a point-of-care or laboratory environment. This system tests blood gases, electrolytes, metabolites, total hemoglo
- Manufacturer
- Siemens Healthcare Diagnostics Inc
- Hazard
- Affected units
- 4,376
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)
- 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 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
- ModerateSiemens Tricyclic Antidepressant Calibrator/Controls Recall Lot U2
FDA (Devices) · 2026-08-12
- LowSyva Emit Disopyramide Enzyme Immunoassay Calibrator Recalled for Sodium Azide Concentration
FDA (Devices) · 2026-08-12
Same hazard · inaccurate reading
See all →- HighMedtronic Guardian Sensor 3 Recall Due to Hydroxyurea Interference
FDA (Devices) · 2021-05-26
- HighMedtronic Guardian Sensor 3 Recall for Hydroxyurea Interaction
FDA (Devices) · 2021-05-26
- HighMedtronic Guardian Sensor 3 Recalled for Inaccurate Glucose Readings
FDA (Devices) · 2021-05-26
- HighMedtronic Guardian Sensor 3 Recall Due to Hydroxyurea Interference
FDA (Devices) · 2021-05-26
- HighMedtronic Guardian Sensor 3 Recall Due to Hydroxyurea Interaction
FDA (Devices) · 2021-05-26