Siemens RAPIDLab 1265 Blood Gas Analyzer Recalled for Hydroxocobalamin Interference
Siemens is recalling 2,357 RAPIDLab 1265 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 involves a risk-of-harm product where the hazard is the potential for altered medical assessment and withheld treatment due to test interference, but no specific injuries or illnesses are reported in the source text.
Plain-English summary
Siemens Healthcare Diagnostics, Inc. is recalling 2,357 units of the RAPIDLab 1265 Blood Gas Analyzer (catalog numbers 110321852, 10470366, and 10491395). 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 covers all units affected and involves nationwide and worldwide foreign distribution.
The recall was initiated because therapeutic levels of Hydroxocobalamin (1mg/mL and 2mg/mL) may interfere with total hemoglobin (tHb) and certain CO-Ox fractions reported by the device. This interference can cause lower-than-expected values for carboxyhemoglobin (fCOHb) and methemoglobin (fMetHb). A negative interference with fCOHb has the potential to alter the medical assessment of the patient, which may result in withholding necessary follow-up treatment or initiating the cessation of medication in response to elevated fMetHb levels.
Healthcare facilities and consumers who have this device should contact Siemens Healthcare Diagnostics, Inc. for further instructions on the recall and potential remediation. The source text does not specify a particular date for the recall or specific instructions for end-users beyond the general recall notice.
The recalled product
- Product
- RAPIDLab 1265 Blood Gas Analyzer; 110321852, 10470366, 10491395 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 tot
- Manufacturer
- Siemens Healthcare Diagnostics, Inc.
- Affected units
- 2,357
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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