Medical Device Recall: Atellica CH Urine Albumin (UAlb). Material Number: 11537225
Siemens Healthcare Diagnostics, Inc. · January 20, 2026
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.
States Affected
NATIONWIDE
Quantity Affected
4,885 units
Source: FDA (openFDA Device Enforcement)
Recall number: Z-1484-2026
Status: ongoing
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