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FDA DeviceClass IINotable

FDA Recall: Atellica CH Urine Albumin (UAlb). Material Number: 11537225

Date: 2026-03-11
Brand: Siemens Healthcare Diagnostics, Inc.
Category: Medical Device
FDA Class: Class II

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.

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.

Remedy

4,885 units

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FDA Recall: Atellica CH Urine Albumin (UAlb). Material Number: 11537225 | RecallWatch