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Recall data is sourced from official U.S. government agencies (CPSC, FDA, NHTSA, USDA) and processed using AI to improve readability. This site is not affiliated with or endorsed by any government agency. Always refer to the original agency notice for authoritative information.

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Medium RiskFDA Device
Medical Devices/Diagnostic Equipment

Siemens Atellica CH UCFP Assay Recalled for Potential Inaccurate Results

Agency Publication Date: September 8, 2025
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Summary

Siemens Healthcare Diagnostics, Inc. is recalling 11,811 units of the Atellica CH Urinary/Cerebrospinal Fluid Protein (UCFP) assay. This recall is being conducted because the product may produce falsely low protein measurements, quality control failures, or delayed test results. Laboratory staff and healthcare providers should stop using the affected assay kits immediately.

Risk

Falsely depressed protein measurements in urine or cerebrospinal fluid can prevent doctors from identifying serious medical conditions, which may lead to a delayed diagnosis or incorrect treatment for the patient.

What You Should Do

  1. This recall affects the Siemens Atellica CH Urinary/Cerebrospinal Fluid Protein (UCFP) assay with Material Number 11097543.
  2. To identify the product, check for UDI-DI 00630414279206 and Test Code UCFP on the packaging; all lot numbers of this material are included in this recall.
  3. Stop using the recalled product. Contact the manufacturer or your distributor to arrange return, replacement, or correction.
  4. Call the FDA at 1-888-463-6332 (1-888-INFO-FDA) if you have any additional questions regarding this recall.

Your Remedy Options

๐Ÿ“‹Other Action
How to: Stop using the recalled product. Contact the manufacturer or your distributor to arrange return, replacement, or correction.

Affected Products

Product: Atellica CH Urinary/Cerebrospinal Fluid Protein (UCFP)
Model / REF:
11097543
Lot Numbers:
All lot numbers
UDI:
00630414279206

Test Code: UCFP. Recall Number: Z-2542-2025.

Additional Information

Agency: Food and Drug Administration (FDA)
Event ID: 97398
Status: Active
Manufacturer: Siemens Healthcare Diagnostics, Inc.
Sold By: Authorized distributors; Hospitals; Clinical laboratories
Manufactured In: United States
Units Affected: 11,811 units
Distributed To: Nationwide

Were You Affected by This Recall?

If you or a family member were harmed by this recalled product, you may have legal rights. Consider consulting a consumer protection attorney to understand your options for compensation.

Find an Attorney

This is general information, not legal advice. Go Backs is not a law firm and does not provide legal services.

AI-Enhanced Content: The summary, action steps, and risk assessment on this page were generated by AI from official government recall data to improve readability. This is not legal or medical advice. Always refer to the official agency sources below for authoritative information.

Sources: FDA iRES ยท Raw API Response

openFDA Disclaimer: This recall information is sourced from the openFDA API. Do not rely on openFDA to make decisions regarding medical care. While we make every effort to ensure that data is accurate, you should assume all results are unvalidated. Refer to the openFDA terms of service for more information.