epoc BGEM BUN Test Card [25pk]. Material Number: 10736515.

Reason: 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.

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.

Distribution pattern: 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.