epoc BGEM BUN Test Card (Siemens) – Sodium Bias (2025)

Check Your Product

According to the U.S. Food and Drug Administration (FDA)

Reason for Recall

As stated by FDA

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.

Recommended Action

Per FDA guidance

Siemens Healthcare Diagnostics notified consignees via letter on about 07/07/2025. Consignees were instructed to review the letter with the Medical Director to determine the appropriate course of action, including for any previously generated results, if applicable, discard and request a replacement of any affected lots or if your institution does not need to report sodium, you can turn off sodium following the instruction of the owner s manual. Consignees were also instructed to complete and return the Field Correction Effectiveness Check Form included with letter, notify customers if products were further distributed, and to retain this letter with your laboratory records and forward this letter to those who may have received this product at your site.