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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

BD COR System Software Recalled for Potential False Negative Results

Agency Publication Date: July 23, 2025
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Summary

Becton Dickinson & Co. is recalling BD COR System Software (Model 444829) because of a software issue in the over-labeling feature. This defect could cause the system to produce false negative test results, which may lead to incorrect patient diagnoses. This recall affects 7 systems using software version 8.80 and above.

Risk

A false negative result means a patient could be told they do not have a condition when they actually do, potentially leading to delayed medical care or incorrect treatment decisions.

What You Should Do

  1. This recall affects the BD COR System Software, Model Number 444829, specifically software version 8.80 and above with UDI-DI 00382904448295.
  2. Stop using the recalled product immediately.
  3. Contact Becton Dickinson & Co. or your authorized distributor to arrange for a software correction, system replacement, or further instructions regarding the over-labeling feature.
  4. Call the FDA at 1-888-463-6332 for additional questions regarding medical device recalls.

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: BD COR System Software
Variants: Software version 8.80 and above
Model / REF:
444829
UDI:
00382904448295

Quantity affected: 7 systems

Additional Information

Agency: Food and Drug Administration (FDA)
Event ID: 97142
Status: Active
Manufacturer: Becton Dickinson & Co.
Sold By: Authorized distributors
Manufactured In: United States
Units Affected: 7 systems
Distributed To: Florida, Texas, Michigan

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.