Device product
Atellica CH Urine Albumin (UAlb). Material Number: 11537225
Z-1484-2026
Product summary
- Event
- Event 98370
- Status
- Ongoing
- Classification
- Class II
- Quantity
- 4,885 units
- Official record key
device-enforcement:Z-1484-2026
Official wording
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 information: Material Number: 11537225. UDI-DI: 00630414611099. Lot Numbers: All lot numbers.
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.
Derived failure modes
-
Unknown
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.