Reported Aug 13, 2025 · Ongoing
epoc BGEM BUN Test Card [25pk]. Material Number: 10736515.
Siemens Healthcare Diagnostics Inc.
Moderate riskThis product could cause temporary or reversible health problems — stop using it.What you should do
Stop using the affected lot and contact the recalling firm for the return or refund process. Check the FDA enforcement report for lot-level detail.
Firm contact: Siemens Healthcare Diagnostics Inc · 2 Edgewater Dr · Norwood, MA · 02062-4637
Is this the product you have?
- epoc BGEM BUN Test Card [25pk]
- Material Number10736515
- Lot codes and dates
- Material Number10736515
- GTIN00809708121860
- Lot Numbers
81 of 81 codes
02-25095-3002-25096-3002-25098-3002-25099-3002-25100-3002-25101-3002-25102-3002-25103-3002-25105-3002-25111-3002-25112-3002-25114-3002-25115-3002-25116-3002-25117-3002-25119-3002-25121-3002-25122-3002-25124-3002-25096-4002-25097-4002-25098-4002-25099-4002-25101-4002-25102-4002-25105-4002-25106-4002-25121-4002-25122-4002-25124-4002-25125-4002-25096-5002-25098-5002-25099-5002-25100-5002-25102-5002-25103-5002-25105-5002-25107-5002-25108-5002-25111-5002-25112-5002-25113-5002-25114-5002-25115-5002-25119-5002-25120-5012-25096-6012-25097-6012-25098-6012-25100-6012-25101-6012-25102-6012-25103-6012-25111-6002-25112-6002-25113-6002-25114-6002-25115-6002-25116-60
- Amount recalled
- 37,554 units
Where it was sold
- Nationwide
Why it was 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.
This product could cause temporary or reversible health problems — stop using it.
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