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Atellica CH Urine Albumin REF: 11537225, in vitro diagnostic recall

Siemens Healthcare Diagnostics, Inc. recalled Atellica CH Urine Albumin REF: 11537225, in vitro diagnostic on August 12, 2026 because of 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. It was sold nationwide.

Why it was recalled

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.

What's recalled

Atellica CH Urine Albumin REF: 11537225, in vitro diagnostic

Quantity: 7018 units

What to do

Check whether you have the product (match the lot numbers, dates or codes in the official notice). Stop using it, and return it or throw it away as the notice says.

Read the official FDA notice

Details

Company
Siemens Healthcare Diagnostics, Inc., Tarrytown, NY
Date
Severity
Class II
the product could cause temporary or reversible health problems.
Where sold
Nationwide
Worldwide distribution - US Nationwide including Puerto Rico and the countries of Australia, Austria, Bahamas, Belgium, Brazil, Canada, Chile, Curacao, St. Eus, Czech Republic, Denmark, Finland, France, Germany, Greece, Hong Kong, Ireland, Israel,¿Italy,¿Latvia, Malaysia, Netherlands, New Zealand,…
Status
Ongoing
Recall number
Z-2890-2026
Source
U.S. Food and Drug Administration

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