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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

Atellica CH Revised C Reactive Protein Assay Recalled for Erroneous Results

Agency Publication Date: April 10, 2025
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Summary

Siemens Healthcare Diagnostics, Inc. has recalled the Atellica CH Revised C Reactive Protein (RCRP) assay due to a software issue that may cause incorrect flagging. This defect could potentially lead to erroneous test results being reported to healthcare providers for patients. This laboratory assay is used in hospitals and medical facilities, and while no injuries or incidents have been reported, the error could impact clinical decisions.

Risk

The software failure may lead to incorrect test results, which could cause a healthcare provider to provide an inaccurate diagnosis or inappropriate medical treatment.

What You Should Do

  1. The recalled product is the Atellica CH Revised C Reactive Protein (RCRP) assay, identified by Siemens Material Number (SMN) 11537223 and UDI-DI 00630414610887. All lot numbers are affected.
  2. Stop using the recalled product.
  3. Contact Siemens Healthcare Diagnostics, Inc. or your authorized distributor to arrange for a return, replacement, or product correction.
  4. Call the FDA at 1-888-463-6332 (1-888-INFO-FDA) for additional assistance 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 Revised C Reactive Protein (RCRP)
Model / REF:
11537223
Lot Numbers:
All lots
UDI:
00630414610887

Recall Number: Z-1551-2025

Additional Information

Agency: Food and Drug Administration (FDA)
Event ID: 96440
Status: Active
Manufacturer: Siemens Healthcare Diagnostics, Inc.
Sold By: Medical laboratories; Hospitals; Healthcare facilities
Manufactured In: United States
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.