Official recall notice
FDA DeviceClass IINotable
FDA Recall: Atellica CH Urine Albumin (UAlb). Material Number: 11537225
- Recall date
- 2026-03-11
- Category
- Medical Device
- FDA class
- Class II
Why it was recalled
Hazard
Falsely depressed UAlb patient results may occur. Affected samples with any urine albumin concentration above the UAlb measuring interval >40.0 mg/dL may report values between 6.2 mg/dL and 40.0 mg/dL.
Recommended action
What to do
4,885 units
Product description
Falsely depressed UAlb patient results may occur. Affected samples with any urine albumin concentration above the UAlb measuring interval >40.0 mg/dL may report values between 6.2 mg/dL and 40.0 mg/dL.