Siemens Healthcare Diagnostics, Inc. recalls Atellica CH Urine Albumin
- Recalling company
- Siemens Healthcare Diagnostics, Inc.
- 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.
- Classification
- Class II – may cause temporary or medically reversible health consequences
- Recall date
- Jan 20, 2026
- Reported
- Mar 11, 2026
- 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.
- Status
- Ongoing
- Quantity
- 4,885 units
- Lot / codes
- Material Number: 11537225. UDI-DI: 00630414611099. Lot Numbers: All lot numbers.
- Company location
- Tarrytown, NY
- Recall type
- Voluntary: Firm initiated
- Recall number
- Z-1484-2026
- Agency
- U.S. Food and Drug Administration (FDA)
View official FDA notice ↗ Search recall number Z-1484-2026 in the FDA Enforcement Report. Also see FDA recall press releases.
If you use this product, check the lot, NDC or model number against the official notice and follow its instructions. Do not stop a prescribed medicine or remove a medical device without talking to your doctor or pharmacist. Report problems to FDA MedWatch. FoodRecallNow summarizes public FDA data and is not medical advice.