epoc BGEM BUN Test Card [25pk]. Material Number: 10736515. — recall Z-2272-2025
U.S. FDA — Device Enforcement · United States · 2025-07-07 · Class II
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Reported risk: 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.
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