Blood Analysis System Software Malfunction May Assign Incorrect Patient Names
Siemens epoc NXS Host blood analysis systems contain a software malfunction that may assign incorrect patient names to blood measurements. This could result in clinicians making treatment decisions based on the wrong patient's test results.
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 FDA recall of a medical device with a software defect that poses a theoretical risk of patient harm through misidentification, without reported injuries. Per the severity rubric, risk-of-harm products where injury has not yet been reported are scored as High (3).
Plain-English summary
The FDA is recalling the Siemens epoc NXS Host blood analysis system (Siemens Material Number 11413506, Software Version 4.14.9) due to a software malfunction. When specific criteria are met, this malfunction can cause an incorrect patient name to be assigned to a blood measurement.
The epoc NXS Host is an in vitro diagnostic device used by trained medical professionals in laboratories and point-of-care settings to perform quantitative testing on arterial, venous, or capillary blood samples. If an incorrect patient name is assigned to a measurement and saved with the test result, clinicians may misdiagnose or mistreat patients based on results incorrectly associated with the wrong individual.
The recalled device consists of 320 units distributed nationwide and internationally, including Canada, the United Kingdom, Australia, and other countries.
The recalled product
- Product
- epoc NXS Host; Siemens Material Number (SMN): 11413506 (CA); 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 capi
- Manufacturer
- Siemens Healthcare Diagnostics, Inc.
- Hazard
- software-malfunction
- patient-misidentification
- misdiagnosis-risk
- mistreatment-risk
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: 11413506
- UDI-DI: 00630414605821
- Software Version Number: 4.14.9.
Distribution
Distributed nationwide across the United States.
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