Siemens Healthcare Diagnostics, Inc.: Atellica CH Enzymatic Hemoglobin A1c (A1c_E). Material Number: 11097536.
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- Company / brand
- Siemens Healthcare Diagnostics, Inc.
- Product
- Atellica CH Enzymatic Hemoglobin A1c (A1c_E). Material Number: 11097536.
- Reason / 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.
- Classification
- Class II
- Status
- Ongoing
- Distribution / sold at
- 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 initiated
- 2026-06-08
- Code info
- Material Number: 11097536. UDI-DI: 00630414220505. All Lot Numbers.
- Product quantity
- 24,077 units
- Voluntary mandated
- Voluntary: Firm initiated
- City
- Tarrytown
- State
- NY
- Country
- United States
- Event id
- 99214
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