Blood Analysis System Software Error Can Assign Wrong Patient Name
Siemens epoc NXS Host blood analysis devices have a software malfunction that may assign the wrong patient name to blood test results, potentially leading to misdiagnosis or mistreatment.
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: This is a Class II medical device recall with no reported illnesses or injuries. The hazard is a software malfunction that could result in patient misidentification, potentially leading to misdiagnosis or mistreatment. No actual harm has been reported, making this a high-risk scenario where injury has not yet occurred.
Plain-English summary
Siemens Healthcare Diagnostics is recalling 2,240 units of the epoc NXS Host blood analysis system due to a software malfunction. The malfunction can incorrectly assign a patient's name to a blood measurement result if the device user does not verify the correct patient name before confirmation.
The affected devices were distributed nationwide and to multiple countries worldwide. These devices are used by trained medical professionals in laboratory and point-of-care settings to perform quantitative blood testing on heparinized, un-anticoagulated, arterial, venous, or capillary whole blood samples.
If a clinician uses incorrect patient information associated with a test result, the device could contribute to misdiagnosis or mistreatment of the patient. Siemens Material Number 11413518 with Software Version 4.14.9 is affected. Healthcare facilities and providers using this device should review their procedures to ensure patient name verification and consider contacting Siemens for device updates or replacement.
The recalled product
- Product
- epoc NXS Host; Siemens Material Number (SMN): 11413518 (ROW) ; Software Version Number: 4.14.9. Intended for use by trained medical professionals as an in vitro diagnostic device for the quantitative testing of samples of heparinized or un-anticoagulated arterial, venous or ca
- Manufacturer
- Siemens Healthcare Diagnostics, Inc.
- Hazard
- software-malfunction
- patient-misidentification
- misdiagnosis
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 (3)
- Siemens Material Number: 11413518
- UDI-DI: 00630414605678
- Software Version Number: 4.14.9.
Distribution
Distributed nationwide across the United States.
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