Reported Jul 15, 2026 · Ongoing
Atellica CH Enzymatic Hemoglobin A1c (A1c_E). Material Number: 11097536.
Siemens Healthcare Diagnostics, Inc.
Moderate riskThis product could cause temporary or reversible health problems — stop using it.What you should do
Stop using the affected lot and contact the recalling firm for the return or refund process. Check the FDA enforcement report for lot-level detail.
Firm contact: Siemens Healthcare Diagnostics, Inc. · 511 Benedict Ave · Tarrytown, NY · 10591-5005
Is this the product you have?
- Atellica CH Enzymatic Hemoglobin A1c (A1c_E)
- Material Number11097536
- Lot codes and dates
- Material Number11097536
- UDI-DI00630414220505. All Lot Numbers
- Amount recalled
- 24,077 units
Where it was sold
- Nationwide
- GA
Why it was 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.
This product could cause temporary or reversible health problems — stop using it.
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