Siemens Healthcare recalls ADVIA Fructosamine test kits that may show 60 umol/L higher glucose levels than actual, risking incorrect diabetes treatment adjustments. Affected kits have specific Siemens Material Numbers.
Fructosamine QC and patient samples may exhibit a 60 umol/L positive bias across the measuring range compared to predicate assay reference leading to a potential adjustment of hyperglycemic therapy. Positively biased fructosamine results may prompt changes in glucose management that may affect glycemia. In extreme situations, more aggressive management of glycemia may occur and contribute to hypoglycemia.
Siemens Healthcare is recalling ADVIA Fructosamine test kits that may show glucose levels 60 umol/L higher than actual. This could lead to incorrect diabetes treatment adjustments, potentially causing dangerous blood sugar drops if patients follow the false readings.
The test kits may show glucose levels 60 umol/L higher than actual. This could lead to incorrect diabetes treatment adjustments, potentially causing dangerous blood sugar drops if patients follow the false readings.
People using ADVIA Fructosamine test kits for diabetes monitoring. Those with diabetes who rely on these tests for treatment adjustments are most at risk.
Check for Siemens Material Number (SMN) 10361941 on the kit. Affected kits were sold with specific Unique Device Identifiers (UDIs) from 2020 to 2021.
Look for Siemens Material Number (SMN) 10361941 on the test kit.
The recall states this could lead to incorrect diabetes treatment adjustments, potentially causing hypoglycemia. However, the hazard is described as low risk and does not mention immediate danger.
Check for Siemens Material Number (SMN) 10361941. Affected kits have specific Unique Device Identifiers (UDIs) from 2020 to 2021.
The recall does not specify a remedy, so you can continue using the kit if you check it's not affected. Contact Siemens Healthcare for more information.
We’ve drafted a message you can send Siemens Healthcare to request your refund or repair — edit it as you like.
Subject: Recall Z-0101-2021 — Siemens Healthcare Siemens Healthcare Hello, I own a Siemens Healthcare that is covered by recall Z-0101-2021 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.
