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Medical Device

Atellica CH Enzymatic Hemoglobin A1c (A1c_E). Material Number: 11097536.

Recall date: 2026-07-15 · Source: FDA_DEVICE
Brand / Firm
Siemens Healthcare Diagnostics, Inc.
Product
Atellica CH Enzymatic Hemoglobin A1c (A1c_E). Material Number: 11097536.
Reason for recall
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.
Units affected
24,077 units
Description
Atellica CH Enzymatic Hemoglobin A1c (A1c_E). Material Number: 11097536.
View official recall notice →