Official recall record
epoc NXS Host Blood Analysis System, Siemens Material Numbers 11413497 (EU), 11413475 (US), 11413506 (CA), 11413517 (MX), 11413518 (ROW), 11
- Issuing authority
- US FDA — Medical Devices
- Recall initiated by firm
- 2023-10-19
- Country of alert
- United States
- Alert level
- Class II
- Alert type
- recall
- Barcode (EAN/GTIN)
- 00630414605760
- Brand on record
- Siemens Healthcare Diagnostics Inc
What the authority reported
Siemens Healthcare Diagnostics Inc. has confirmed a potential issue that could occur under certain conditions, a software problem is causing erroneous results to be printed. 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. The worst possible outcome may result in a failure to diagnose hyperkalemia, due to an erroneous depressed potassium level or inappropriate treatment to hyperglycemia due to erroneous glucose reading.
What to do
Follow the instructions in the official notice — recall remedies (refund, repair, replacement, or disposal) are defined by the issuing authority and the responsible business, and they differ per recall. Do not rely on summaries, including this one.
Record last checked against the registry on 2026-05-31.
Other recalls from this brand
- 2025-07-07 · US FDA — Medical Devices
epoc BGEM BUN Test Card [25pk]. Material Number: 10736515. - 2025-06-26 · US FDA — Medical Devices
RAPIDPoint 500 Systems Wash/Waste Cartridge (4 Pack). Material Number: 10329097. - 2024-09-24 · US FDA — Medical Devices
epoc BGEM BUN Test Card (25 pk) for the epoc Blood Analysis System, SMN 10736515
All 38 official recall notices naming Siemens Healthcare Diagnostics, Inc. on this site →