Siemens Healthcare recalls epoc BGEM BUN Test Cards with potential negative sodium bias that could affect blood test accuracy. No injuries reported, but affected lots expired before recall.
Siemens Healthcare Diagnostics Inc. has confirmed that a negative sodium bias may exist in one lot of epoc BGEM BUN Test Cards approximately 2 months prior to expiration. The observed maximum negative bias from internal testing is -10 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. One customer complaint has been associated with this issue. No adverse events have been reported. All affected lots have recently expired before the issuance of the recall.
Siemens Healthcare is recalling epoc BGEM BUN Test Cards that may show negative sodium bias in blood tests. This could lead to inaccurate results, but no injuries have been reported. The affected lots expired before the recall was issued.
The test cards may show a negative sodium bias, meaning blood test results could be too low for sodium. This could affect diagnosis but does not cause immediate harm. Quality control fluids might not detect the issue consistently.
Users of the epoc Blood Analysis System with the recalled test cards are affected. Those who recently used expired test cards may be at slightly higher risk due to potential inaccurate test results.
Check for lot numbers 08-24092-60 through 08-24096-60 on the test card packaging. The test cards are for the epoc Blood Analysis System and expired before the recall was issued.
Look for lot numbers 08-24092-60 through 08-24096-60 on the test card packaging.
No adverse events have been reported.
Check for lot numbers 08-24092-60 through 08-24096-60 on the test card packaging.
The recall does not require stopping use, but affected test cards may have inaccurate results.
We’ve drafted a message you can send Siemens Healthcare to request your refund or repair — edit it as you like.
Subject: Recall Z-0286-2025 — Siemens Healthcare Siemens Healthcare Hello, I own a Siemens Healthcare that is covered by recall Z-0286-2025 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.
