Siemens Healthcare recalls specific epoc test cards that may show falsely high glucose levels for samples near the lower end of the reportable range. Affected units include certain software versions and lot numbers with expiry dates through August 2023.
There is potential for discrepant high glucose results in samples with glucose results on the lower end of the reportable range.
Siemens Healthcare is recalling epoc test cards that may show higher glucose results than actual for samples with glucose levels at the lower end of the reportable range. This could lead to incorrect diabetes management decisions if the test results are used without knowing the issue.
The test card software may misread glucose levels when results are near the lower limit of what the device can report. This could cause a false high reading, potentially leading to incorrect diabetes treatment decisions.
People using Siemens epoc test cards with specific software versions and lot numbers (expiring through August 2023) are affected. Those managing diabetes with these test cards are most at risk.
Check for the model name 'epoc BGEM Crea Test Card' with software versions v3.37.3 (Host) and v4.10.6 (NXS), and lot numbers 03-23002-60 (expires June 19, 2023) or 03-23056-50 (expires August 12, 2023).
Look for the model name 'epoc BGEM Crea Test Card' with specific software versions and lot numbers listed in the recall notice.
The recall does not require stopping use; it only identifies a potential for inaccurate results. You can continue using the test cards but should verify results with a different method if concerns arise.
The recall does not provide a remedy, so no action is needed. However, you can check the test card details against the list provided to confirm if it is affected.
Check for the model name 'epoc BGEM Crea Test Card' with software versions v3.37.3 (Host) and v4.10.6 (NXS), and lot numbers 03-23002-60 (expires June 19, 2023) or 03-23056-50 (expires August 12, 2023).
We’ve drafted a message you can send Siemens Healthcare to request your refund or repair — edit it as you like.
Subject: Recall Z-2477-2023 — Siemens Healthcare Siemens Healthcare Hello, I own a Siemens Healthcare that is covered by recall Z-2477-2023 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.
