Siemens Healthcare Diagnostics, Inc. recalls Atellica CH Enzymatic Hemoglobin A1c

Recalling company

Siemens Healthcare Diagnostics, Inc.

Product

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

Reason

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.

Classification

Class II – may cause temporary or medically reversible health consequences

Recall date

Jun 8, 2026

Reported

Jul 15, 2026

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.

Status

Ongoing

Quantity

24,077 units

Lot / codes

Material Number: 11097536. UDI-DI: 00630414220505. All Lot Numbers.

Company location

Tarrytown, NY

Recall type

Voluntary: Firm initiated

Recall number

Z-2703-2026

Agency

U.S. Food and Drug Administration (FDA)

View official FDA notice ↗ Search recall number Z-2703-2026 in the FDA Enforcement Report. Also see FDA recall press releases.