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FDAJanuary 20, 2026device

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

Official recall recorded by the U.S. Food & Drug Administration.

The 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.

What to do

FDA enforcement status: Ongoing

Brands named

siemens healthcare diagnosticssiemenssiemens healthcare

UPCs

00630414611099

Recall history

Other federal recalls tied to the same brand — a factual pattern, straight from the source data.

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