FDA Enforcement
Class II
Ongoing
Atellica CH Urine Albumin (UAlb). Material Number: 11537225
Recall: Z-1484-2026
·
Reported March 11, 2026
Enforcement
- Recall Number
- Z-1484-2026
- Event ID
- 98370
- Classification
- Class II
- Status
- Ongoing
- Product Type
- Devices
- Firm
- Siemens Healthcare Diagnostics, Inc.
- Voluntary / Mandated
- Voluntary: Firm initiated
- Initial Notification
- Letter
- Report Date
- March 11, 2026
- Initiation Date
- January 20, 2026
- Classification Date
- March 2, 2026
- Address
- 511 Benedict Ave, N/A, Tarrytown, NY, 10591-5005, United States
Description
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.
Code Info
Material Number: 11537225. UDI-DI: 00630414611099. Lot Numbers: All lot numbers.
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.
Quantity
4,885 units