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Recall Observatory FDA recall evidence

Device product

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

Z-1484-2026

January 20, 2026

Class II

Product summary

Firm
Siemens Healthcare Diagnostics, Inc.
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

    reason.no_named_rule · v1.0.0

    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.