epoc BGEM BUN Test Card [25pk]. Material Number: 10736515.
FDA Recall #Z-2272-2025 — Class II — July 7, 2025
Product Description
epoc BGEM BUN Test Card [25pk]. Material Number: 10736515.
Reason for Recall
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.
Recalling Firm
Siemens Healthcare Diagnostics Inc — Norwood, MA
Classification
Class II — May cause temporary or medically reversible adverse health consequences.
Product Type
Devices
Product Quantity
37,554 units
Distribution
Worldwide distribution - US Nationwide and the countries of Argentina, Austria, Bahrain, Bolivia, Brazil, Canada, Canary Islands, Chile, Croatia, Denmark, Ecuador, Estonia, France, Fren. Polynesia, Germany, Greece, Guatemala, Hungary, Iceland, India, Indonesia, Ireland, Israel, Italy, Jordan, Kazakhstan, Lithuania, Malaysia, Martinique, Mexico, Morocco, Netherlands, New Caledonia, Paraguay, Philippines, Poland, Portugal, Qatar, Rep. Korea (S), Romania, Russian Fed., San Marino, Slovakia, Slovenia, South Africa, Spain, Srilanka, Sweden, Switzerland, Taiwan, Thailand, Turkey, Uganda, Ukraine, Unit.Arab Emir., United Kingdom, Uruguay, Japan.
Code Information
Material Number: 10736515. GTIN: 00809708121860. Lot Numbers: 02-25095-30, 02-25096-30, 02-25098-30, 02-25099-30, 02-25100-30, 02-25101-30, 02-25102-30, 02-25103-30, 02-25105-30, 02-25111-30, 02-25112-30, 02-25114-30, 02-25115-30, 02-25116-30, 02-25117-30, 02-25119-30, 02-25121-30, 02-25122-30, 02-25124-30, 02-25096-40, 02-25097-40, 02-25098-40, 02-25099-40, 02-25101-40, 02-25102-40, 02-25105-40, 02-25106-40, 02-25121-40, 02-25122-40, 02-25124-40, 02-25125-40, 02-25096-50, 02-25098-50, 02-25099-50, 02-25100-50, 02-25102-50, 02-25103-50, 02-25105-50, 02-25107-50, 02-25108-50, 02-25111-50, 02-25112-50, 02-25113-50, 02-25114-50, 02-25115-50, 02-25119-50, 02-25120-50, 12-25096-60, 12-25097-60, 12-25098-60, 12-25100-60, 12-25101-60, 12-25102-60, 12-25103-60, 12-25111-60, 02-25112-60, 02-25113-60, 02-25114-60, 02-25115-60, 02-25116-60, 02-25117-60, 02-25118-60, 02-25120-60, 02-25121-60, 02-25122-60, 02-25123-60, 02-25124-60, 02-25099-70, 02-25101-70, 02-25104-70, 02-25105-70, 02-25107-70, 02-25108-70, 02-25110-70, 02-25111-70, 02-25112-70, 02-25113-70, 02-25115-70, 02-25116-70, 02-25118-70, 02-25120-70.
Status
Ongoing
Voluntary / Mandated
Voluntary: Firm initiated
What Should You Do?
Stop using this medical device immediately and consult your healthcare provider. Contact the recalling firm for instructions on return or replacement. If you experienced an adverse event, inform your doctor.