Siemens Healthcare recalls Atellica CH Systems Fructosamine test kits that may show 60 umol/L higher glucose levels than actual, risking incorrect diabetes treatment adjustments. Affected kits have specific serial numbers and were sold from 2021 to 2022.
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 Atellica 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 low blood sugar if patients are over-treated.
The test kits may show glucose levels 60 umol/L higher than actual. This could lead to patients receiving too much insulin or other diabetes treatments, potentially causing dangerously low blood sugar.
People using Atellica Fructosamine test kits for diabetes monitoring. Those with diabetes who rely on these tests for treatment adjustments are most at risk.
Check for the Siemens Material Number (SMN) 11097637 on the kit. Affected kits were sold from 2021 to 2022 with specific serial numbers listed in the recall notice.
Look for the Siemens Material Number (SMN) 11097637 on the test kit. Affected kits have specific serial numbers listed in the recall notice.
No. The recall states the risk is low, as the error is small and unlikely to cause immediate harm.
No. The recall does not require stopping use; it only recommends checking the serial numbers to identify affected kits.
Check for the Siemens Material Number (SMN) 11097637 on the kit. Affected kits were sold from 2021 to 2022 with specific serial numbers listed in the recall notice.
We’ve drafted a message you can send Siemens Healthcare to request your refund or repair — edit it as you like.
Subject: Recall Z-0102-2021 — Siemens Healthcare Siemens Healthcare Hello, I own a Siemens Healthcare that is covered by recall Z-0102-2021 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.
