Siemens Healthcare Diagnostics Inc recalls epoc BGEM BUN Test Card [25pk]. Material Number: 10736515.

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.

Siemens Healthcare Diagnostics notified consignees via letter on about 07/07/2025. Consignees were instructed to review the letter with the Medical Director to determine the appropriate course of action, including for any previously generated results, if applicable, discard and request a replacement of any affected lots or if your institution does not need to report sodium, you can turn off sodium following the instruction of the owner s manual. Consignees were also instructed to complete and return the Field Correction Effectiveness Check Form included with letter, notify customers if products were further distributed, and to retain this letter with your laboratory records and forward this letter to those who may have received this product at your site.

• FDA enforcement recordOfficial FDA database entry for Z-2272-2025
• FDA 510(k) clearance · K200107The device's official FDA premarket clearance record
• FDA device classification · JGSOfficial FDA classification for this device type
• CFR regulation · 21 CFR 862.1665The federal regulation governing this device
• FDA recall announcementSearch FDA.gov for the official press announcement
• Find Siemens Healthcare Diagnostics IncSearch for the manufacturer's official notice
• News coverageRecent reporting on this recall and manufacturer
• openFDA data recordThe raw JSON record this page is built from

Source: U.S. FDA openFDA device enforcement reports. This summary is informational and may lag or differ from the official record. Always verify against the FDA before acting.