Atellica CH Enzymatic Hemoglobin A1c recall
Atellica CH Enzymatic Hemoglobin A1c (A1c_E). Material Number: 11097536.
Why was Atellica CH Enzymatic Hemoglobin A1c recalled?
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 should I do if I have this product?
The recall is ongoing. Follow the firm and FDA instructions.
What to do with a recalled product: refunds, receipts, safe disposal and how to report a problem.
Is my product affected?
Compare the item in your hand with every identifier below from the official FDA record. Only products that match the listed product and lot, UPC or model codes are part of this recall.
Which lot codes, UPCs or models are affected?
Material Number: 11097536. UDI-DI: 00630414220505. All Lot Numbers.
- Product
- Atellica CH Enzymatic Hemoglobin A1c (A1c_E). Material Number: 11097536.
- Recalling firm
- Siemens Healthcare Diagnostics, Inc.
- Quantity
- 24,077 units
- 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.
- Recall date
- July 15, 2026
- Classification
- Class II
- Status
- Ongoing
- Agency
- FDA (device)