FDA recall, , Moderate risk
Atellica CH Enzymatic Hemoglobin A1c (A1c_E)
The assay has a potential for intermittent well-to-well bias.
Summary by Recall Canary from the FDA notice
What happened
Siemens Healthcare Diagnostics, Inc., located in Tarrytown, New York, began a recall on June 8, 2026, for the Atellica CH Enzymatic Hemoglobin A1c (A1c_E) assay, Material Number 11097536. The FDA added the recall to its Enforcement Report on July 8, 2026, and it was classified the same day. The recall involves 24,077 units and was distributed nationwide in the US and worldwide in many countries.
The potential for intermittent well-to-well bias on the A1c_E assay on the Atellica CH and Atellica CI analyzer could cause falsely depressed or falsely elevated HbA1c patient results. The recall was included in the FDA's weekly enforcement report on July 15, 2026.
What to do
We don't have product-specific instructions for this recall. FDA's general advice for medical device recalls:
- A device recall doesn't always mean you must stop using it: it may need to be checked, adjusted or fixed.
- Talk to your health care provider before you stop using it.
Is yours affected?
Affected if its UDI-DI is listed.
A UDI-DI is the device identifier printed with the barcode on the device label.
Atellica CH Enzymatic Hemoglobin A1c (A1c_E). Material Number: 11097536.
- UDI-DI
- 11097536
- 00630414220505
- Lot code
- All Lot Numbers
Recall details
- Company began the recall
- Sold in
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.
- Company
- Siemens Healthcare Diagnostics, Inc.Tarrytown, New York
- Hazard
- Device defect
- Risk
Moderate risk
Using it may cause short-term health problems, or ones that treatment can reverse. Serious harm is unlikely.
FDA Class II recall · How risk is rated
- Event ID
- 99214
- Recall number
- Z-2703-2026
- Quantity recalled
- 24,077 units
All recalls from Siemens Healthcare Diagnostics, Inc.
Timeline
FDA's Enforcement Report is its public list of recalls; FDA adds a recall when it posts it and publishes the list weekly.
Company began the recall
Added to FDA's Enforcement Report · Classified by FDA
Listed on Recall Canary
In FDA's weekly enforcement report
Summary updated
