# FDA device recall: Atellica CH Enzymatic Hemoglobin A1c (A1c_E). Material Number: 11097536.

> recall · VERIFIED · 2026-06-08

Firm: Siemens Healthcare Diagnostics, Inc. · Class II · 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.

- Company: Siemens Healthcare Diagnostics, Inc.
- Primary source: https://www.fda.gov/safety/recalls-market-withdrawals-safety-alerts

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Source: MedFuel Intel news monitor. Verification tier: VERIFIED. Informational only, not investment advice. Corrections: media@medfuelinc.com.