Siemens Healthcare recalls Epoc BGEM BUN Test Cards with potential sodium bias. Affected lots may show inaccurate sodium readings. No remedy specified in official notice.
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 is recalling Epoc BGEM BUN Test Cards that may show inaccurate sodium readings. This could lead to incorrect blood test results if used without proper calibration. The issue affects specific production lots.
The test cards may show sodium readings up to 14 mmol/L lower than actual levels. This negative bias could cause inaccurate blood test results, especially at higher sodium concentrations. No positive bias has been observed.
People using Epoc BGEM BUN Test Cards for blood testing may be affected. Those with frequent blood tests or sensitive sodium monitoring are at higher risk.
Check for lot numbers starting with 02- or 12- followed by 25096-30 through 25124-70 in the product's serial code. The product is sold as a 25-pack of Epoc BGEM BUN Test Cards with Material Number 10736515.
Look for lot numbers in the format 02-25096-30 to 02-25124-70 on the test card packaging.
No remedy is specified in the official recall notice, so you do not need to stop using them immediately.
The test cards may show sodium readings up to 14 mmol/L lower than actual levels, which could lead to inaccurate results, especially at higher sodium concentrations.
The official recall notice does not specify any remedy, so no corrective actions are required.
We’ve drafted a message you can send Siemens Healthcare to request your refund or repair — edit it as you like.
Subject: Recall Z-2272-2025 — Siemens Healthcare Siemens Healthcare Hello, I own a Siemens Healthcare that is covered by recall Z-2272-2025 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.
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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.
