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Siemens Healthcare Diagnostics, Inc. Recall

Atellica CH Urine Albumin REF: 11537225, in vitro diagnostic

Updated July 6, 2026

Siemens Healthcare Diagnostics, Inc. is recalling Atellica CH Urine Albumin REF: 11537225, in vitro diagnostic. 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.

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

Am I affected

You may be affected if you own this product. Check the brand, model, and lot/date codes listed in the recall against your item.

What to do right now

Voluntary: Firm initiated

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

Siemens Healthcare Diagnostics, Inc.
Source
FDA
Category
Drugs & Medications
Recall ID
fda-Z-2890-2026
Classification
Class II
Recalled
July 6, 2026
Read the official notice

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