Siemens Atellica CH Urine Albumin Recall
Atellica CH Urine Albumin REF: 11537225, in vitro diagnostic
Updated July 6, 2026
Siemens Atellica CH Urine Albumin test kits may produce falsely low results for urea nitrogen and hemoglobin A1c levels, or experience delayed results due to quality control failures. This can lead to misdiagnosis and incorrect patient care decisions.
Is the Siemens Healthcare Diagnostics, Inc. recalled? Yes. This product was recalled by FDA on July 6, 2026. Details below.
What is recalled
Atellica CH Urine Albumin REF: 11537225, in vitro diagnostic test kits manufactured by Siemens Healthcare Diagnostics, Inc.
Am I affected
You are affected if your laboratory uses Atellica CH Urine Albumin REF: 11537225 test kits on Siemens CI analyzers.
What to do right now
Contact Siemens Healthcare Diagnostics, Inc. immediately to report any affected test kits in your facility and to request a replacement or corrective action. Do not rely on results from this test kit without verification from Siemens.
The hazard
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.
Brands affected
- Source
- FDA
- Category
- Medical Devices
- Recall ID
- fda-Z-2890-2026
- Classification
- Class II
- Recalled
- July 6, 2026
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