Siemens recalls Atellica CH Enzymatic Hemoglobin A1c (A1c_E) devices due to potential for false low or high blood sugar results. Affected units may need recalibration or replacement.
The potential for intermittent well-to-well bias on the A1c_E assay on the Atellica CH and Atellica CI analyzer which could cause falsely depressed or falsely elevated HbA1c patient results.
Siemens is recalling Atellica CH Enzymatic Hemoglobin A1c (A1c_E) devices because they might give inaccurate blood sugar test results. This could lead to incorrect diabetes management decisions if the device is used without correction.
The device may produce false low or high HbA1c results during testing. This could lead to incorrect diabetes management decisions if the device is used without correction.
Diabetes patients using the Atellica CH A1c_E test device with material number 11097536 are affected. Those who rely on accurate blood sugar monitoring for diabetes management are most at risk.
Check for the material number 11097536 on the device. All lot numbers are affected. The product is sold by Siemens Healthcare Diagnostics.
Look for the material number 11097536 on the Atellica CH A1c_E device.
The Atellica CH Enzymatic Hemoglobin A1c (A1c_E) device may produce false low or high HbA1c results, which could lead to incorrect diabetes management decisions.
Check for the material number 11097536 on the device. All lot numbers are affected.
The recall record does not specify a remedy, so contact Siemens Healthcare Diagnostics for guidance.
We’ve drafted a message you can send Siemens Healthcare to request your refund or repair — edit it as you like.
Subject: Recall Z-2703-2026 — Siemens Healthcare Siemens Healthcare Hello, I own a Siemens Healthcare that is covered by recall Z-2703-2026 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.
