epoc BGEM BUN Test Card (Siemens) – pH result discrepancy (2025)
Hazard assessment based on recall description.
This AI-generated summary is provided for general informational purposes only and is derived from publicly available recall notices. It supplements but does not replace official agency classifications or safety instructions.
Check Your Product
According to the U.S. Food and Drug Administration (FDA)
Product
epoc BGEM BUN Test Card (25 pk) for the epoc Blood Analysis System; Siemens Material Number (SMN): 10736515; epoc Software Version & Sensor Configuration: epoc Host SW v3.41.2, epoc NXS SW v4.14.9 & 4.14.11, Sensor Configuration 45.n.
Brand
Siemens Healthcare Diagnostics Inc
Lot Codes / Batch Numbers
Siemens Material Number (SMN): 10736515, Udi-DI: 00809708121860, Lot Numbers: All lot numbers with prefix (xx) 02 or 12, epoc Software Version and Senor Configuration: epoc Host SW V3.41.2, epoc NXS SW v4.14.9 & 4.14.11, Sensor Configuration 45.n.
Products Sold
Siemens Material Number (SMN): 10736515; Udi-DI: 00809708121860; Lot Numbers: All lot numbers with prefix (xx) 02 or 12; epoc Software Version and Senor Configuration: epoc Host SW V3.41.2, epoc NXS SW v4.14.9 & 4.14.11, Sensor Configuration 45.n.
Siemens Healthcare Diagnostics Inc is recalling epoc BGEM BUN Test Card (25 pk) for the epoc Blood Analysis System; Siemens Material Number (SMN): 1 due to The occurrence of discrepant high pH results in samples introduced with higher injection volumes with epoc sensor configuration 45.n.. Based on FDA medical device recall database.
Summary derived from FDA notice
Reason for Recall
As stated by FDA
The occurrence of discrepant high pH results in samples introduced with higher injection volumes with epoc sensor configuration 45.n.
Recommended Action
Per FDA guidance
Consignees were sent an Urgent Medical Device Correction notice dated March 2025. The notification instructs consignees to review the provided notice with their medical director to determine the appropriate course of action. If affected devices were further distributed consignees are asked to forward the recall notification. Consignees are to return the provided Field Correction Effectiveness Check form within 7 days of receipt. The firm recommends that consignees stop injecting the sample as soon as the audio/visual cues are presented to minimize the potential for erroneous pH results. The current affected software expires on 06/10/25 and the upgrade will include a correction for this issue. Consignees are to retain the recall notification with their manual or near the system for reference. Consignees with questions can call the Siemens Healthineers Technical Solutions Center at 877-229-3711.
Verify this information on the official source
For complete details and official instructions, check the U.S. Food and Drug Administration (FDA) directly.
View official FDA recall noticePage updated: Jan 10, 2026