Siemens Healthcare recalls specific epoc BGEM BUN Test Cards with certain software versions due to potential for high glucose results in low glucose samples. Affected units include specific lots and expiry dates.
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 BGEM BUN Test Cards with specific software versions because they may show falsely high glucose results for samples with low glucose levels. This could lead to incorrect diabetes management decisions if the test is used without noticing the discrepancy.
The test card may produce higher glucose results than actual when the sample's glucose level is near the lower end of the reportable range. This could cause inaccurate diabetes management decisions if the test is used without noticing the discrepancy.
People using the epoc BGEM BUN Test Card with the specified software versions and lots are affected. Those managing diabetes with this test card are most at risk of incorrect readings.
Check for the specific software versions: epoc Host SW v3.37.3, epoc NXS SW v4.10.6, and Sensor Configuration 41.1. Also look for the listed lots and expiry dates on the product packaging.
Verify the software versions on the test card: epoc Host SW v3.37.3, epoc NXS SW v4.10.6, and Sensor Configuration 41.1.
Check the lot numbers listed: 04-23003-60 (expiry 20-Jun-2023), 11-22337-60 (expiry 20-May-2023), 04-23034-40 (expiry 21-Jul-2023), 04-23059-50 (expiry 15-Aug-2023), 04-23059-60 (expiry 15-Aug-2023), and 04-23069-40 (expiry 25-Aug-2023).
The test card may produce higher glucose results than actual for samples with glucose levels near the lower end of the reportable range, which could lead to incorrect diabetes management decisions.
Check for the specific software versions: epoc Host SW v3.37.3, epoc NXS SW v4.10.6, and Sensor Configuration 41.1, along with the listed lot numbers and expiry dates.
No, the recall does not require immediate stoppage. Affected users should check the software and lot numbers to confirm if their test card is affected.
We’ve drafted a message you can send Siemens Healthcare to request your refund or repair — edit it as you like.
Subject: Recall Z-2476-2023 — Siemens Healthcare Siemens Healthcare Hello, I own a Siemens Healthcare that is covered by recall Z-2476-2023 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.
