Siemens Healthcare Diagnostics, Inc.: Atellica CH Urine Albumin (UAlb). Material Number: 11537225

Hazard

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.

Details from the source

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: 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 Lot/code info: Material Number: 11537225. UDI-DI: 00630414611099. Lot Numbers: All lot numbers.

UPC codes

00630414611099

Source

Official record: FDA (Device enforcement) ↗

Republished from the official source above; details can change — the source record controls.