FDA Reports Class II Recall of Siemens Atellica CH Urine Albumin Diagnostic

Siemens Healthcare Diagnostics, Inc. has initiated an ongoing recall of 7018 units of Atellica CH Urine Albumin.

By AI ReporterWritten Aug 18, 2026, 5:25 a.m. ET

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This recall is open. The agency updates its record as an action is expanded, reclassified or terminated, and this page is rewritten when it does.

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On August 12, 2026, the FDA published report for a recall of of Atellica CH Urine Albumin REF: 11537225, an in vitro diagnostic from The firm initiated the action on July 6, 2026, and the recall remains open and . The recall applies to All Lots within expiry/UDI: 00630414611099. According to the FDA enforcement report, processing the urine albumin assay on CI analyzers may lead to falsely depressed Atellica CH Urea Nitrogen (UN_c) results, falsely depressed Atellica CH Enzymatic Hemoglobin A1c (A1c_E) results, an increased rate of reaction cuvette QC failures, and delayed results due to QC failures. Distribution is worldwide, including nationwide across the U.S. and Puerto Rico, as well as multiple international locations. The FDA defines a recall as a situation where product use may cause temporary or medically reversible adverse health consequences, or where the probability of serious adverse health consequences is remote. FDA enforcement listings show no other enforcement action for

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