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

Medical DevicesSource: FDA (device) · Date: 2026-03-11

Read the official notice at FDA (device) →

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The text below is copied from the official FDA (device) record. If anything differs, the official notice is correct.

Company / brand
Siemens Healthcare Diagnostics, Inc.
Product
Atellica CH Urine Albumin (UAlb). Material Number: 11537225
Reason / 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.
Classification
Class II
Status
Ongoing
Distribution / sold at
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.
Recall initiated
2026-01-20
Code info
Material Number: 11537225. UDI-DI: 00630414611099. Lot Numbers: All lot numbers.
Product quantity
4,885 units
Voluntary mandated
Voluntary: Firm initiated
City
Tarrytown
State
NY
Country
United States
Event id
98370
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