FDAClass II · Medical device · Recalled July 15, 2026
Atellica CH Enzymatic Hemoglobin A1c (A1c_E) recall — Siemens Healthcare Diagnostics, Inc.
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.
Class II: may cause temporary or medically reversible health consequences.
View the official FDA enforcement record (openFDA) ↗
- Official recall ID
- Z-2703-2026
- Brand
- Siemens Healthcare Diagnostics
- Classification
- Class II
- Units affected
- 24,077 units
- Recall status
- Ongoing
- Initiated
- Voluntary: Firm initiated
Description
Atellica CH Enzymatic Hemoglobin A1c (A1c_E). Material Number: 11097536.
Affected products
Companies & origin
- Recalling firm location
- Tarrytown, NY, United States
- Firm address
- 511 Benedict Ave, N/A, 10591-5005
Identifying details (verbatim from the notice)
- Product codes / lots
- 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.
- Firm notified the public via
- Letter
- FDA event ID
- 99214
- Recall initiated
- June 8, 2026
- FDA classified
- July 8, 2026
- FDA report date
- July 15, 2026
Source: U.S. Food & Drug Administration. This page mirrors the official public-domain record verbatim;
the linked government source is authoritative. Source last checked July 23, 2026 at 10:00 PM UTC.
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