| Type of Product |
Medical Device |
| TGA Recall Reference |
RC-2023-RN-00978-1 |
| Product Name/Description |
epoc NXS Host. An in vitro diagnostic medical device (IVD)
Software Version: From 4.9.4 to the current version 4.11.11
Material Number: 11413518
Unique Device Identification (UDI-DI): 00630414605678
ARTG 198575
(Siemens Healthcare Pty Ltd - Instrument/analyser IVDs) |
| Recall Action Level |
Hospital |
| Recall Action Classification |
Class II |
| Recall Action Commencement Date |
10/11/2023 |
| Responsible Entity |
|
| Reason/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 Action |
Product Defect Correction |
| Recall Action Instructions |
Customers should review the customer letter wit their Medical Director to determine the appropriate course of action, including for any previously generated results, if applicable.
To mitigate this issue, customers should follow the instructions in the letter to set Delete Blood Test settings to NEVER and continue using device as normal.
Siemens advises that this issue will be corrected with the next NXS software version (4.12.XX) which must be installed by December 12, 2023, when current software version (4.11.11) expires. |
| Contact Information |
1800 310 300 - Siemens Customer Care Centre or Craig Hodkinson on 0439 768 894 |