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Health Canada Medical devices

epoc® NXS Host – 5553CA

Issued November 17, 2023
Issue
Siemens Healthcare Diagnostics Inc. has confirmed a potential issue that could occur under specific conditions when the (automatic) delete blood tests feature is enabled. When the results are run on the epoc® NXS host and delete blood tests feature is enabled, the results that are generated at the time of testing are correct; however, when this issue occurs, results that are printed, saved and/or transferred to a data manager, may include unselected analytes that are from a previous patient or QC test. Recall start date: October 24, 2023
Hazard description
Performance
Product
Product name
epoc® NXS Host – 5553CA
Reference
ID
RA-74607