Recall Z-1484-2026— Siemens Healthcare Diagnostics, Inc.

Name: FDA recall Z-1484-2026
Creator: U.S. Food and Drug Administration
Published: 2026-01-20

Class II · Ongoing

Class II FDA medical device recall by Siemens Healthcare Diagnostics, Inc., initiated 2026-01-20. FDA's recall record names no specific 510(k) clearance for this event. Product: Atellica CH Urine Albumin (UAlb). Material Number: 11537225. Reason: 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..

Recalling firm: Siemens Healthcare Diagnostics, Inc.
Classification: Class II
Status: Ongoing
Initiated: 2026-01-20
Firm location: Tarrytown, NY, United States

Product description

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

Reason for recall

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.

Data sourced from openFDA. This site is unofficial and independent of the FDA.