Siemens Healthcare Diagnostics, Inc. — Class II: Atellica CH Urine Albumin REF: 11537225, in vitro diagnostic
Siemens Healthcare Diagnostics has initiated a Class II recall for the Atellica CH Urine Albumin assay due to interference issues on CI analyzers that can cause falsely depressed results for Urea Nitrogen (UN_c) and Enzymatic Hemoglobin A1c (A1c_E). The issue also leads to increased reaction cuvette QC failures and subsequent testing delays.
Laboratories utilizing the Atellica CH Urine Albumin (REF: 11537225) on CI analyzers, as well as clinical personnel relying on Urea Nitrogen and HbA1c diagnostic data from these systems.
The technical interference between assays presents a risk of clinical misinterpretation due to falsely depressed results in unrelated diagnostic panels. From a regulatory and operational perspective, the increased rate of QC failures suggests a systemic issue with assay compatibility on the shared analyzer platform, necessitating a review of multi-assay processing logic and potential CAPA activities.
Verify if current laboratory inventory includes the affected REF number and assess whether Urea Nitrogen or HbA1c results were reported during periods of cuvette QC failure. Review internal procedures for managing reagent-driven analyzer interference and ensure QC failure protocols are strictly followed.
Class II. Reason: Processing of urine albumin assay on the CI analyzers may lead to the following issues: Falsely depressed Atellica CH Urea Nitrogen (UN_c) results; Falsely depressed Atellica CH Enzymatic Hemoglobin A1c (A1c_E) results; Increased rate of reaction cuvette QC failures and Delayed results due to QC failures.. Product: Atellica CH Urine Albumin REF: 11537225, in vitro diagnostic. Firm: Siemens Healthcare Diagnostics, Inc. (Tarrytown NY United States). Status: Ongoing.
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