Official recall notice
FDA DeviceClass IINotable
FDA Recall: Atellica CH Enzymatic Hemoglobin A1c (A1c_E). Material Number: 11097536.
- Recall date
- 2026-07-15
- Category
- Medical Device
- FDA class
- Class II
Why it was recalled
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.
Product 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.
Affected products
Material Number: 11097536. UDI-DI: 00630414220505. All Lot Numbers.