Atellica CH Enzymatic Hemoglobin A1c (A1c_E): recall status

Notice names this product. Siemens Healthcare Diagnostics’s Atellica CH Enzymatic Hemoglobin A1c (A1c_E) is named in FDA Class II recall Z-2703-2026. Your particular item is not yet verified. Compare the identifiers and exclusions in the notice before deciding whether it applies. Agency-reported hazard: 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. Identifying details: Material Number: 11097536. UDI-DI: 00630414220505. All Lot Numbers.. Units affected: 24,077 units. Status: Ongoing.

1. Compare your item

This notice names a product; your particular item is not yet verified. Compare every applicable model, serial, lot, production-date or model-year boundary below.

Product named: Atellica CH Enzymatic Hemoglobin A1c (A1c_E)
Company / brand: Siemens Healthcare Diagnostics
Lot / serial / date codes: Material Number: 11097536. UDI-DI: 00630414220505. All Lot Numbers.
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 Republic Congo, Denmark, Ecuador, Egypt, El Salvador, Estonia, Finland, France, Georgia, Germany, Greece, Hong Kong, India, Indonesia, Israel, Italy, Japan, Jordan, Kenya, Kuwait, Latvia, Lebanon, Lithuania, Macedonia, Malaysia, Mexico, Netherlands, New Zealand, Norway, Oman, Pakistan, Paraguay, Poland, Portugal, Qatar, Republic of Korea, Romania, Saudi¿Arabia, Serbia, Singapore, Slovakia, Slovenia, South Africa, Spain, Switzerland, Thailand, Turkey, Turkmenistan, U.A.E., Uganda, United¿Kingdom, Uruguay, Vatican City, Vietnam.

Agency product description and boundaries

Atellica CH Enzymatic Hemoglobin A1c (A1c_E). Material Number: 11097536.

Still to verify: match the label on your item with the full official notice, including any exclusions, tables and photos. Some identifiers appear only on the agency website and are absent from this data feed. A missing field does not mean all versions are affected.

If your lot or date falls outside a stated range, this notice has not established that your item is affected. This is not a finding about other recalls or product safety.

Brand: Siemens Healthcare Diagnostics

Recalls naming this model

FDA Class II · Medical device · July 15, 2026

Atellica CH Enzymatic Hemoglobin A1c (A1c_E) recall — Siemens Healthcare Diagnostics, Inc.

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 patien…

Company / brand: Siemens Healthcare Diagnostics

Affected product: Atellica CH Enzymatic Hemoglobin A1c (A1c_E)

Official ID Z-2703-2026 · Official record ↗

See all Siemens Healthcare Diagnostics recalls →

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FDA — food, drugs, medical devices ↗ (aggregated here)
USDA FSIS — meat, poultry & processed egg products ↗ (not aggregated here)
Recalls.gov — the U.S. government’s all-agency portal ↗

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Compiled from connected official public-domain government data. Sources last checked September 7, 2026 at 6:00 AM UTC.