Siemens RAPIDPoint 405 Blood Gas Analyzer Recalled for Sample Misidentification Risk
Siemens is recalling RAPIDPoint 405 blood gas analyzers because users may enter incorrect patient IDs, leading to sample misidentification.
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: The recall involves a risk-of-harm product (medical device) where sample misidentification could lead to incorrect patient care, but no injuries or illnesses have been reported in the source text.
Plain-English summary
Siemens Healthcare Diagnostics Inc is recalling 4,494 units of the RAPIDPoint 405 system blood gas analyzer. The recall covers units distributed worldwide, including the United States and numerous international markets. The affected devices are intended for near-patient and laboratory testing of blood gases, electrolytes, metabolites, and hemoglobin derivatives in whole blood samples.
The recall is due to a software issue where users of the RAPIDPoint 400 Series, RAPIDPoint 500, or RAPIDLab 1200 Series blood gas analyzers can inadvertently enter a wrong patient ID on the demographics screen. This error could ultimately lead to the misidentification of the sample. The source text does not report any specific illnesses, injuries, or deaths associated with this defect.
Healthcare facilities and users of these systems should contact Siemens Healthcare Diagnostics Inc for further instructions on how to address the issue. The recall applies to all serial numbers of the affected models.
The recalled product
- Product
- Siemens RAPIDPoint¿¿ 405 system blood gas analyzer Product PUsage: These systems are intended for near-patient and laboratory testing of blood gases, electrolytes, metabolites, total hemoglobin, and hemoglobin derivatives in arterial, venous, and capillary whole blood samples
- Manufacturer
- Siemens Healthcare Diagnostics Inc
- Affected units
- 4,494
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
Distributed nationwide across the United States.
Part of a larger recall action
This product is one of 7 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 7 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 · misidentification
See all →- HighOxoid Microbact Listeria kit may identify the incorrect organism
FDA (Devices) · 2026-04-08
- HighBD Phoenix diagnostic systems may misidentify E. coli in clinical samples
FDA (Devices) · 2024-10-02
- HighDiagnostic Kit Recalled for False Positive Bacterial Identification Results
FDA (Devices) · 2022-12-07
- HighBD Vacutainer Luer Lok Access Device may shed particles causing false test results
FDA (Devices) · 2022-03-02
- HighAPI ID 32 C Diagnostic Strips Recalled Due to Thermoforming Defect
FDA (Devices) · 2022-02-02