Siemens RAPIDPoint 405 Blood Gas Analyzer Recalled for Interference
Siemens is recalling RAPIDPoint 405 Blood Gas Analyzers because Hydroxocobalamin may interfere with test results, potentially leading to incorrect medical assessments.
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 is classified as FDA Class II, and the source text describes a risk of harm where incorrect medical assessments could lead to withheld or altered treatment, but no specific injuries or illnesses are reported.
Plain-English summary
Siemens Healthcare Diagnostics, Inc. is recalling 2,248 units of the RAPIDPoint 405 Blood Gas Analyzer. The affected devices are point-of-care systems used for comprehensive lab-quality testing at the patient's bedside, including blood gas, electrolytes, glucose, hematocrit, neonatal total bilirubin, and full CO-oximetry tests.
The recall is due to the potential for therapeutic levels of Hydroxocobalamin (1mg/mL and 2mg/mL) to interfere with total hemoglobin (tHb) and certain CO-Ox fractions. This interference may cause lower than expected values for carboxyhemoglobin (fCOHb) and methemoglobin (fMetHb). Such inaccuracies could alter the medical assessment of a patient, potentially leading to the withholding of necessary follow-up treatment or the cessation of medication in response to elevated fMetHb levels.
The affected units were distributed nationwide and worldwide. Consumers and healthcare facilities should contact Siemens Healthcare Diagnostics, Inc. for further instructions on how to handle the recalled devices.
The recalled product
- Product
- RAPIDPoint 405 Blood Gas Analyzer; 10282093, 10310464, 10314817, 10317193, 10318999, 10320055, 10321238, 10322347, 10328278, 10328302, 10336784 Device is point-of-care system for comprehensive lab-quality testing to patient's bedside. Test menu includes blood gas, electrolyt
- Manufacturer
- Siemens Healthcare Diagnostics, Inc.
- Affected units
- 2,248
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 units affected
Distribution
Distributed nationwide across the United States.
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 · test interference
See all →- HighSiemens Atellica Lab Analyzers Risk Falsely Elevated Cholesterol Results
FDA (Devices) · 2024-04-24
- HighFetal Membrane Rupture Test Kits Recalled for False Positive Results
FDA (Devices) · 2024-04-24
- HighAbbott Alinity i Anti-HCV Reagent Kit Recall for Falsely Elevated Test Results
FDA (Devices) · 2024-04-10
- HighHepatitis B Diagnostic Test Kits Recalled for Test Interference
FDA (Devices) · 2023-03-01
- HighFDA Recalls V8 Immunodisplacement Kit Due to Microbial Contamination
FDA (Devices) · 2022-06-15