Siemens recalls epoc BGEM BUN Test Cards (25 pack) with specific software and sensor settings that may cause inaccurate high pH results in blood tests.
The occurrence of discrepant high pH results in samples introduced with higher injection volumes with epoc sensor configuration 45.n.
Siemens is recalling epoc BGEM BUN Test Cards (25 pack) that may give false high pH results when used with certain software versions and sensor configurations. This could lead to incorrect blood test interpretations, but the risk is not immediately dangerous to users.
The test cards may produce inaccurate high pH readings when used with higher injection volumes in the epoc sensor configuration 45.n. This happens with specific software versions and sensor settings, which could lead to incorrect blood test interpretations.
Users of the epoc Blood Analysis System with the specific test cards and software versions listed in the recall. Laboratory staff and healthcare providers are most at risk due to potential for inaccurate test results.
Check for the Siemens Material Number (SMN) 10736515, software versions epoc Host SW v3.41.2 and epoc NXS SW v4.14.9 or 4.14.11, and sensor configuration 45.n. The test cards were sold with lot numbers starting with '02' or '12' in the specific software versions.
Verify your epoc Blood Analysis System software versions match the specific versions listed in the recall.
Ensure your sensor configuration is set to 45.n as specified in the recall.
No, the recall does not require immediate discontinuation. The risk is low and only affects specific software and sensor configurations.
The affected software versions are epoc Host SW v3.41.2 and epoc NXS SW v4.14.9 or 4.14.11.
Check for Siemens Material Number (SMN) 10736515, lot numbers starting with '02' or '12', and sensor configuration 45.n with the specified software versions.
We’ve drafted a message you can send Siemens Healthcare to request your refund or repair — edit it as you like.
Subject: Recall Z-1684-2025 — Siemens Healthcare Siemens Healthcare Hello, I own a Siemens Healthcare that is covered by recall Z-1684-2025 from Siemens Healthcare. I’m writing to arrange the remedy described in the recall (a refund, repair, or replacement as applicable). Could you please tell me the next steps to resolve this? Thank you.
Experiences, tips, and questions from readers. Every comment is reviewed before it appears.
No comments yet — be the first to share your experience.
The facts (hazard, remedy, dates, manufacturer) are pulled from the official FDA recall record. The plain-language summary and step-by-step checklist are written by GovInfoNow to make the official notice easier to act on — they don’t replace it.
