FDAJuly 7, 2025device

epoc BGEM BUN Test Card [25pk]. Material Number: 10736515.

Official recall recorded by the U.S. Food & Drug Administration.

The hazard

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

FDA enforcement status: Ongoing

Brands named

siemens healthcare diagnosticssiemenssiemens healthcare

UPCs

00809708121860

Recall history

Other federal recalls tied to the same brand — a factual pattern, straight from the source data.

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