FDA DeviceClass IINotable
FDA Recall: Atellica CH Enzymatic Hemoglobin A1c (A1c_E). Material Number: 11097536.
Description
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.
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.
Remedy
24,077 units
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