Siemens Healthcare Diagnostics, Inc. recalls Atellica CH Urine Albumin (UAlb). Material Number: 11537225

Recall date

January 20, 2026

Source

U.S. Food & Drug Administration (FDA) — enforcement report

Recall number

Z-1484-2026

FDA classification

Class II

Brand / firm

Siemens Healthcare Diagnostics, Inc.

Sold / distributed

Worldwide distribution - US Nationwide and the countries of Australia, Austria, Belgium, Brazil, Canada, Chile, Curacao,¿St¿Eus, Czech¿Republic, Denmark, Finland, France, Germany, Greece, Hong Kong, Ireland, Israel, Italy, Korea, Latvia, Malaysia, Netherlands, New Zealand, Norway, Portugal, Romania…

Why it was recalled

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.

Class II means using this product may cause temporary or medically reversible health problems; the chance of serious harm is remote.

What was recalled

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