Siemens RAPIDPoint 500 Blood Gas Analyzer Recalled for Hydroxocobalamin Interference
Siemens recalls RAPIDPoint 500 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 hazard involves a risk of harm (altered medical assessment and withheld treatment) where specific injury reports are not stated in the source text, fitting the 'High' severity criteria for risk-of-harm products.
Plain-English summary
Siemens Healthcare Diagnostics, Inc. is recalling the RAPIDPoint 500 Blood Gas Analyzer. The recall involves 10,199 units that were distributed nationwide and worldwide. The device is a point-of-care system used for comprehensive lab-quality testing at the patient's bedside, including blood gas, electrolytes, glucose, lactate, and CO-oximetry tests.
The recall is due to a potential interference issue where therapeutic levels of Hydroxocobalamin (1mg/mL and 2mg/mL) may affect the total hemoglobin (tHb) and certain CO-Ox fractions reported by the device. This interference may cause lower than expected values for carboxyhemoglobin (fCOHb) and methemoglobin (fMetHb).
Inaccurate readings of carboxyhemoglobin and methemoglobin have the potential to alter the medical assessment of a patient. This could result in withholding necessary follow-up treatment or initiating the cessation of medication in response to elevated methemoglobin levels. Users should contact Siemens Healthcare Diagnostics for further instructions on handling the affected devices.
The recalled product
- Product
- RAPIDPoint 500 Blood Gas Analyzer; 10492730, 1069855, 10696857, 10697306 Device is point-of-care system for comprehensive lab-quality testing to patient's bedside. Test menu includes blood gas, electrolytes, glucose, lactate, neonatal total bilirubin and full CO-oximetry incl
- Manufacturer
- Siemens Healthcare Diagnostics, Inc.
- Affected units
- 10,199
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.
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