Potential health hazard — use of or exposure to this product may cause temporary or medically reversible adverse health consequences.
epoc BGEM BUN Test Card [25pk]. Material Number: 10736515. Recalled by Siemens Healthcare Diagnostics Inc Due to Siemens Healthcare Diagnostics Inc. has confirmed that a...
What You Should Do
Stop using this product immediately. Do not consume, use, or distribute it.
Return the product to the place of purchase for a full refund. If you have questions, contact Siemens Healthcare Diagnostics Inc directly.
Affected Products
epoc BGEM BUN Test Card [25pk]. Material Number: 10736515.
Quantity: 37,554 units
Why Was This Recalled?
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.
Where Was This Sold?
This product was distributed nationwide across all 50 states.
About Siemens Healthcare Diagnostics Inc
Siemens Healthcare Diagnostics Inc has 75 total recalls tracked by RecallDetector.
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Data sourced from the FDA (Device). Last updated March 26, 2026. View original report