Recall Z-2890-2026— Siemens Healthcare Diagnostics, Inc.
Class II · Ongoing
Class II FDA medical device recall by Siemens Healthcare Diagnostics, Inc., initiated 2026-07-06. FDA's recall record names no specific 510(k) clearance for this event. Product: Atellica CH Urine Albumin REF: 11537225, in vitro diagnostic. 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..
- Recalling firm
- Siemens Healthcare Diagnostics, Inc.
- Classification
- Class II
- Status
- Ongoing
- Initiated
- 2026-07-06
- Firm location
- Tarrytown, NY, United States
Product description
Atellica CH Urine Albumin REF: 11537225, in vitro diagnostic
Reason for recall
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.
Data sourced from openFDA. This site is unofficial and independent of the FDA.