epoc® Blood Analysis BGEM Test Cards

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.

Recall start date: July 9, 2025