# Major Recall Alert: epoc® Blood Analysis BGEM Test Cards Recalled Due to Negative Sodium Bias
Siemens Healthcare Diagnostics Inc. has announced a critical recall of specific lots of epoc® Blood Analysis BGEM Test Cards starting July 9, 2025. The issue stems from a **negative sodium bias**, which could significantly impact the accuracy of certain test results. While all other analytes are performing as intended, the sodium results may show incorrect readings, with an **average bias of -4.4 mmol/l and a maximum bias of -14 mmol/l**. No positive biases have been observed so far.
Healthcare professionals and facilities currently utilizing these test cards should be aware of this potential risk and take prompt action to ensure patient safety.
## Why This Recall is Important
Accurate lab test results are the cornerstone of modern healthcare, enabling informed decisions about diagnosis, treatment, and management. A consistent **negative sodium bias** in test results could have serious implications, especially in critical care settings where sodium levels are closely monitored and adjusted.
### Key factors to note:
- **Affected Product**: epoc® Blood Analysis BGEM Test Cards.
- **Issue Identified**: Negative sodium bias.
- **Impact**: Observed average bias of -4.4 mmol/l; a maximum bias of -14 mmol/l at sodium concentrations near 150 mmol/l.
- **Detection Limitations**: Quality control (QC) fluids may not consistently detect the issue depending on the bias magnitude and the frequency of QC testing.
These discrepancies in sodium measurements could lead to delayed or incorrect treatment decisions, particularly in critical care situations where rapid and precise results are essential.
## Details of the Recall
On **July 9, 2025**, Siemens Healthcare Diagnostics Inc. initiated this recall in Canada after confirming the presence of a sodium bias in certain test card lots. Importantly:
- **Other Analytes Are Unaffected**: The recall solely pertains to sodium measurements; other tests performed using the cards remain accurate and reliable.
- **Bias Observed During High Sodium Levels**: The maximum bias of -14 mmol/l was observed at elevated sodium concentrations, approximately 150 mmol/l.
The recall highlights the challenge of identifying the issue using routine QC protocols. Healthcare practitioners are urged to exercise caution and verify test results if discrepancies are suspected.
For the official recall notice, visit the [Government of Canada’s Recall Alerts](https://recalls-rappels.canada.ca/en/alert-recall/epocr-blood-analysis-bgem-test-cards).
## What You Should Do
Healthcare providers and facilities using the affected epoc® Blood Analysis BGEM Test Cards should take the following immediate steps:
- **Identify Affected Lots**: Verify whether your current stock includes recalled test card lots.
- **Discontinue Use**: Stop using the impacted lots immediately to prevent inaccurate sodium readings.
- **Contact Siemens Healthcare Diagnostics Inc.**: Reach out to the manufacturer using the contact information provided in the official recall notice for further guidance on returns or replacements.
- **Check QC Protocols**: Review and adjust quality control procedures to ensure continued accuracy for other tests.
Patients and caregivers should consult their healthcare providers about any concerns related to recent blood test results involving sodium measurements.
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Click [here](https://recalls-rappels.canada.ca/en/alert-recall/epocr-blood-analysis-bgem-test-cards) to read the full official recall notice and ensure you're up to date on all necessary precautions.
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