Lower risk Medical device recall · FDA · Published June 8, 2026

Siemens Atellica CH A1c_E Test Recall: False HbA1c Results Risk

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.

Plain-English summary generated from official FDA data by GovInfoNow · Published by Carlos Caban · How we make summaries

🇺🇸 FDA recall #Z-2703-2026Medical device Siemens Healthcare ›

Lower-risk recall

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.

Take action

Contact the company

Recalling firmSiemens Healthcare Diagnostics, Inc.511 Benedict Ave · Tarrytown, NY 10591-5005

✎ GovInfoNow plain-language explainer

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. Read more at govinfonow.com/recall/49034-siemens-atellica-ch-a1c-e-test-recall-false-hba1c-results.

Source Summary by GovInfoNow · govinfonow.com/recall/49034-siemens-atellica-ch-a1c-e-test-recall-false-hba1c-results · Updated August 10, 2026 · FDA enforcement record: FDA #Z-2703-2026

Cite this page

“Siemens Atellica CH A1c_E Test Recall: False HbA1c Results Risk.” GovInfoNow, updated August 10, 2026. https://govinfonow.com/recall/49034-siemens-atellica-ch-a1c-e-test-recall-false-hba1c-results. Based on FDA recall #Z-2703-2026 (https://api.fda.gov/device/enforcement.json?search=recall_number:%22Z-2703-2026%22&limit=1).

The FDA announced on June 8, 2026, that Siemens Healthcare Diagnostics is recalling Atellica CH Enzymatic Hemoglobin A1c (A1c_E) reagent due to potential bias causing falsely depressed or elevated HbA1c results. The agency issued recall number Z-2703-2026 for the Class II voluntary recall.

How to tell if you have it

Brand: Siemens Healthcare
Product: Atellica CH Enzymatic Hemoglobin A1c (A1c_E)
Material Number: 11097536
UDI-DI: 00630414220505
Lot Numbers: All Lot Numbers
Units affected: 24,077

The hazard

The recall cites the potential for intermittent well-to-well bias on the A1c_E assay on the Atellica CH and Atellica CI analyzers. This issue could cause falsely depressed or falsely elevated HbA1c patient results.

Context

GovInfoNow's records show Siemens Healthcare Diagnostics has had 150 other recalls since June 7, 2017. Other recent recalls of similar products include Atellica CH Revised C-Reactive Protein (RCRP) recall (2026-08-17), Siemens Healthcare Syva EMIT 2000 Quinidine Assay Recall (2026-07-13), and Siemens Atellica CH Urine Albumin Recall (2026-07-06). Other recent recalls of similar products include GET TESTED International AB Diabetes HbA:1c Test Recall (2025-11-03), Abbott Diabetes Care FreeStyle Libre 3 Plus Sensor Recall (2025-11-24), and LH One Step Ovulation Test Device Recall (2025-11-22).

How to tell if you have this one

Check for the material number 11097536 on the device. All lot numbers are affected. The product is sold by Siemens Healthcare Diagnostics.

Brand
Siemens Healthcare
Category
Medical device

Based on the official FDA remedy

What to do — step by step

Check Device Details
Look for the material number 11097536 on the Atellica CH A1c_E device.

Where it went and when

Where it was distributed

Distributed nationwide, and outside the U.S.

FDA distribution: “Worldwide distribution - US Nationwide and the countries of Argentina, Australia, Austria, Bahamas, Bangladesh, Bolivia, Brazil, Bulgaria, Burkina¿Faso, Canada, Chile, China, Colombia, Croatia, Cura¿ao,¿St¿Eus, Czech¿Republic, Democratic…” States read from FDA’s own wording; “not listed” means the notice does not name it.

Distributed nationwide, and outside the U.S.

Recall timeline

FDA published this recall 37 days after the firm started it.

Jun 8, 2026Firm started the recall
Jul 8, 2026FDA classified it Class II
Jul 15, 2026Published in FDA’s Enforcement Report

Dates from the agency record only; steps without a date are left out.

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Keep exploring

More Siemens Healthcare recalls

Link to this recall

<a href="https://govinfonow.com/recall/49034-siemens-atellica-ch-a1c-e-test-recall-false-hba1c-results">Siemens Atellica CH A1c_E Test Recall: False HbA1c Results Risk (GovInfoNow)</a>

Where this comes from

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.

Official source: FDA Recall #Z-2703-2026 (June 8, 2026) — FDA publishes no per-recall page; this is the official machine-readable enforcement record. Search FDA recalls for Z-2703-2026 to see it in context.
Plain-language summary written by qwen3:4b on August 10, 2026, from the official record above. Not reviewed by a person — if it conflicts with the FDA notice, the notice is correct. Report an error on this page.
GovInfoNow is an independent service and is not a government agency. We republish official FDA recall data; we don’t issue, amend or administer recalls.