Siemens Healthcare recalls specific epoc test cards that may show falsely high glucose levels in samples with low glucose results. Affected units include veterinary test cards with certain software versions and sensor configurations.
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 specific epoc test cards that may give falsely high glucose results for samples with glucose levels near the lower end of the reportable range. This could lead to incorrect health decisions if used without knowing the issue.
The test cards may produce higher glucose results than actual levels when samples have glucose values at the lower end of the reportable range. This could cause incorrect health decisions if the user relies on the test results without knowing the issue.
People using Siemens epoc test cards for blood glucose testing, especially those with veterinary use. Those who rely on these cards for accurate glucose readings are most at risk.
Check for the model name 'epoc BGEM Test Card (BUN & TCO2)' with software versions v3.37.3 or v4.10.6 and sensor configuration 41.1. The lot number is 04-23043-51 with an expiry date of July 30, 2023.
Look for the model name, software versions, and sensor configuration listed in the product description.
The test cards may produce higher glucose results than actual levels for samples with glucose values at the lower end of the reportable range.
The recall does not specify a remedy, so check with Siemens Healthcare for further instructions.
The hazard is limited to potential inaccurate glucose results, not a physical risk of injury.
We’ve drafted a message you can send Siemens Healthcare to request your refund or repair — edit it as you like.
Subject: Recall Z-2478-2023 — Siemens Healthcare Siemens Healthcare Hello, I own a Siemens Healthcare that is covered by recall Z-2478-2023 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.
