Atellica CH Enzymatic Hemoglobin A1c Assay
Siemens is recalling the Atellica CH Enzymatic Hemoglobin A1c assay (Material No. 11097536) due to potential for inaccurate patient results.
Review patient results generated using the affected assay and consult with clinical staff to determine if retesting is required. Contact Siemens Healthcare Diagnostics for further instructions regarding the use of this product.
Recall at a glance
- Quantity recalled
- 24,077 units
Why it was recalled
Siemens Healthcare Diagnostics is recalling the Atellica CH Enzymatic Hemoglobin A1c (A1c_E) assay due to intermittent well-to-well bias. This issue can lead to falsely depressed or falsely elevated HbA1c patient results on the Atellica CH and Atellica CI analyzers.
Is mine affected?
Check the model, lot, or serial number on the device or its packaging. Yours is affected if it matches one below.
Atellica CH Enzymatic Hemoglobin A1c (A1c_E). Material Number: 11097536.
- Lot code
- All Lot Numbers
- UDI-DI
- 11097536, 00630414220505
Where it was sold
Distributed nationwide.
Timeline
- Firm initiated recall
- Publicly announced
- Listed on Recall Canary
- Summary updated
Official source
Other Device Defect recalls
Other recent recalls from Siemens Healthcare Diagnostics, Inc.
Editorial summary by Recall Canary · summary updated 2026-07-09 · primary source: U.S. Food and Drug Administration · severity reflects the agency's published classification