Siemens RAPIDLab Blood Gas Analyzer Recalled for Hydroxocobalamin Interference
Siemens Healthcare Diagnostics is recalling 138 RAPIDLab 1245 Blood Gas Analyzers because Hydroxocobalamin may interfere with test results, potentially leading to incorrect medical assessments.
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 involves a medical device where inaccurate test results could lead to incorrect medical assessments and treatment decisions, fitting the 'High' severity criteria for risk-of-harm products where injury has not yet been reported.
Plain-English summary
Siemens Healthcare Diagnostics, Inc. is recalling 138 units of the RAPIDLab 1245 Blood Gas Analyzer. The affected units are identified by model numbers 10321844, 10337179, and 10491393. These devices are point-of-care systems 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). Such inaccuracies have the potential to alter the medical assessment of a patient, which could result in withholding necessary follow-up treatment or initiating the cessation of medication in response to elevated fMetHb levels.
The affected units were distributed nationwide and worldwide. All units of the specified models are affected. Healthcare facilities and users should stop using the affected devices and contact Siemens Healthcare Diagnostics for further instructions on the recall process.
The recalled product
- Product
- RAPIDLab 1245 Blood Gas Analyzer; 10321844, 10337179, 10491393 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 including…
- Manufacturer
- Siemens Healthcare Diagnostics, Inc.
- Affected units
- 138
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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