Siemens Healthcare Diagnostics, Inc. — Atellica CH Urine Albumin (UAlb). Material Number: 11537225
⚠️ 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.
Is this relevant to me?
- Geography
- Nationwide
- Source agency
- FDA
- Category
- Health
- Published
- January 20, 2026
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.
What's affected?
- Product
- Atellica CH Urine Albumin (UAlb). Material Number: 11537225
- Lot code
- All
Additional details
Material Number: 11537225. UDI-DI: 00630414611099. Lot Numbers: All lot numbers.
What should I do?
Recommended action
Class II recall. Voluntary: Firm initiated Quantity affected: 4,885 units.
Get Health recall alerts
Delivered to your inbox. Free. No account required.