Siemens recalls epoc BGEM Crea Test Cards (25 pack) for potential high pH results with certain software versions. Affected units have specific model numbers and software configurations.
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 Crea Test Cards (25 pack) because they can cause inaccurate high pH results when used with specific software versions. This means test results might be wrong, which could affect medical decisions.
The test cards can produce higher pH results when more blood is injected into the sensor with certain software configurations. This inaccuracy might lead to incorrect blood pH readings, which could affect medical decisions.
Users of the epoc Blood Analysis System with the specific test cards and software versions listed in the recall. Patients and healthcare providers who rely on these test cards for blood pH measurements are most at risk.
Check for the Siemens Material Number (SMN) 10736382 on the test cards. The affected units have specific software versions (epoc Host SW v3.41.2, epoc NXS SW v4.14.9 or 4.14.11) and sensor configuration 45.n.
Verify the software version on your epoc Blood Analysis System to see if it matches the affected versions listed in the recall.
Reach out to Siemens Healthcare for guidance on whether your test cards are affected and what steps to take next.
The recall indicates potential inaccuracies with specific software versions and configurations, so it's best to check if your system matches the affected versions before using.
Check for the Siemens Material Number (SMN) 10736382 and ensure your software versions and sensor configuration match the affected ones listed in the recall.
Contact Siemens Healthcare directly for specific guidance on whether to stop using or replace the test cards.
We’ve drafted a message you can send Siemens Healthcare to request your refund or repair — edit it as you like.
Subject: Recall Z-1685-2025 — Siemens Healthcare Siemens Healthcare Hello, I own a Siemens Healthcare that is covered by recall Z-1685-2025 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.
