Official recall record
epoc BGEM BUN Test Card [25pk]. Material Number: 10736515.
- Issuing authority
- US FDA — Medical Devices
- Alert date
- 2025-07-07
- Country of alert
- United States
- Alert level
- Class II
- Alert type
- recall
- Brand on record
- Siemens Healthcare Diagnostics Inc
What the authority reported
Siemens Healthcare Diagnostics Inc. has confirmed that a negative sodium bias may exist in some epoc test card lots. All other analytes are performing as intended. The observed average bias for sodium was -4.4 mmol/L. The maximum bias observed was -14 mmol/L, which occurred at a higher sodium concentration around 150 mmol/L. No positive bias has been observed. Quality Control (QC) fluid may or may not detect the issue depending on the bias magnitude and the frequency of QC testing.
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
- 2025-06-26 · 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 - 2024-05-17 · US FDA — Medical Devices
Software version 5.3 in: RAPIDPoint 500e Blood Gas System (USA) Siemens Material Number: 11416751 RAPID