Atellica CH Urine Albumin (UAlb). Material Number: 11537225
FDA Recall #Z-1484-2026 — Class II — January 20, 2026
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.
Recalling Firm
Siemens Healthcare Diagnostics, Inc. — Tarrytown, NY
Classification
Class II — May cause temporary or medically reversible adverse health consequences.
Product Type
Devices
Product Quantity
4,885 units
Distribution
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, Singapore, Slovakia, South Africa, Spain, Sweden, Switzerland, United¿Kingdom.
Code Information
Material Number: 11537225. UDI-DI: 00630414611099. Lot Numbers: All lot numbers.
Status
Ongoing
Voluntary / Mandated
Voluntary: Firm initiated