Atellica CH Enzymatic Hemoglobin A1c recall (Siemens Healthcare Diagnostics, Inc.)
Medical deviceClass IIOngoing
Summary: Siemens Healthcare Diagnostics, Inc. is recalling 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.
What is being recalled
Atellica CH Enzymatic Hemoglobin A1c (A1c_E). Material Number: 11097536.
Why
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.
How serious is it
Class II is the middle level: using or being exposed to this product may cause temporary or medically reversible health problems, and the chance of serious harm is remote.
Where it was sold
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. (states named: Georgia)
How to tell if yours is affected
Material Number: 11097536. UDI-DI: 00630414220505. All Lot Numbers.
What to do
Check the model, lot or serial numbers above against your device. If yours is affected, contact the manufacturer or your healthcare provider before you stop using a device you rely on.
Recall facts
| Recall number | Z-2703-2026 |
| Category | Medical device |
| Agency | U.S. Food and Drug Administration (FDA) |
| Severity | Class II |
| Status | Ongoing |
| Recall started | June 8, 2026 |
| Reported | July 15, 2026 |
| Company | Siemens Healthcare Diagnostics, Inc. |
| Company location | Tarrytown, NY, United States |
| Initiated by | Voluntary: Firm initiated |
| Quantity | 24,077 units |
More recalls from Siemens Healthcare Diagnostics, Inc. · all medical device recalls · recalls from June 2026