FDA-Device2026-03-11Class II

Atellica CH Urine Albumin (UAlb). Material Number: 11537225

Siemens Healthcare Diagnostics, Inc.

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.

Sold states

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.

Affected count

4,885 units

Manufactured in

511 Benedict Ave, N/A, Tarrytown, NY, United States

Products

Atellica CH Urine Albumin (UAlb). Material Number: 11537225

Official notice

https://www.accessdata.fda.gov/scripts/ires/index.cfm?Product=Z-1484-2026

Original summary

Atellica CH Urine Albumin (UAlb). Material Number: 11537225 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. 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. Affected quantity: 4,885 units

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