Official recall record

epoc® Blood Analysis BGEM Test Cards

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. Recall start date: July 9, 2025

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.

More recalls: Health Canada — Medical Devices · Canada · all filters