Z-1484-2026 Class II Ongoing
Recall Details
- Product Type
- Devices
- Report Date
- March 11, 2026
- Initiation Date
- January 20, 2026
- Termination Date
- N/A
- Voluntary/Mandated
- Voluntary: Firm initiated
- Product Quantity
- 4,885 units
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.
Distribution Pattern
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.