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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

Beckman Coulter, Inc.: DxI 9000 Immunoassay Analyzer Recalled for Software Errors and Testing Delays

Agency Publication Date: August 9, 2024
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Summary

Beckman Coulter is recalling 183 DxI 9000 Access Immunoassay Analyzers (software versions 1.17 and below) because a software error can cause communication failures when connected to laboratory automation systems. This defect triggers "out of sequence" messages and pick-and-place errors that prevent the machine from completing diagnostic tests. Without a correct result, there is a significant risk of delays in reporting patient test results, which can postpone critical medical treatments. Consumers should contact their healthcare provider or Beckman Coulter at 1-800-526-3821 for guidance.

Risk

A software bug causes the analyzer to send incorrect sequence messages to automated laboratory systems, leading to sample handling errors or missing test results. This failure can result in incorrect or delayed medical diagnoses and treatment plans for patients.

What You Should Do

  1. Identify if your laboratory is using the Beckman Coulter DxI 9000 Access Immunoassay Analyzer, specifically Catalog #C11137 with software versions 1.17 or below.
  2. Check the device for UDI-DI 15099590732103 to confirm it is part of the affected 183 units.
  3. If your analyzer is connected to a Laboratory Automation System (LAS) and you encounter 'out of sequence' messages, 'sample pick and place (PnP)' errors, or 'no result obtained (NRT)' flags, contact Beckman Coulter technical support immediately.
  4. Contact Beckman Coulter at 1-800-526-3821 or visit their website for information regarding software updates or corrective patches for this issue.
  5. Report any adverse events or quality problems experienced with the use of this product to the FDA's MedWatch Adverse Event Reporting program at 1-800-FDA-1088.
  6. For additional questions, contact the FDA hotline at 1-888-463-6332 (1-888-INFO-FDA).

Your Remedy Options

๐Ÿ“‹Other Action

Software update or technical support intervention

How to: Contact your healthcare provider or the manufacturer (Beckman Coulter) at 1-800-526-3821 for further instructions and potential refund

Affected Products

Product: Beckman Coulter DxI 9000 Access Immunoassay Analyzer
Model / REF:
Catalog #C11137
Lot Numbers:
Software versions 1.17 and below
UDI-DI 15099590732103

Additional Information

Agency: Food and Drug Administration (FDA)
Event ID: 94841
Status: Active
Manufacturer: Beckman Coulter, Inc.
Sold By: Beckman Coulter; Direct laboratory sales
Manufactured In: United States
Units Affected: 183 devices
Distributed To: California, Florida, Georgia, Indiana, Kansas, Maine, New Hampshire, New Jersey, Oklahoma, Pennsylvania, Texas

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.