Beckman Coulter, Inc.: DxI 9000 Immunoassay Analyzer Recalled for Potential Leaking and Safety Hazards

Agency Publication Date: August 30, 2024

Summary

Beckman Coulter, Inc. is recalling 17 units of the DxI 9000 Access Immunoassay Analyzer because of manufacturing cracks discovered on the internal wash buffer tank. These cracks can cause fluid to leak from the wash buffer supply drawer, which may lead to equipment damage, delays in patient test results, and potential exposure to physical or chemical hazards. This diagnostic device is used by healthcare professionals to measure various substances in human body fluids.

Risk

Cracks around a threaded insert on the bottom of the wash buffer tank can cause leaks, creating a risk of physical injury from chemical exposure or hazardous spills, and may result in incorrect or delayed medical diagnoses due to equipment failure.

What You Should Do

Identify if your laboratory or facility is using the DxI 9000 Access Immunoassay Analyzer (REF C11137) with UDI/DI 15099590732103.
Check the serial number of your unit against the following affected list: 300254, 300256, 300257, 300258, 300259, 300263, 300264, 300266, 300268, 300269, 300270, 300271, 300272, 300273, 300275, 300281, and 300282.
Contact your healthcare provider or Beckman Coulter, Inc. immediately for further instructions regarding inspection and potential equipment repair or replacement.
Report any equipment malfunctions or suspected leaks to the manufacturer to ensure environmental and physical safety.
For additional questions or to report issues, contact the FDA at 1-888-463-6332 (1-888-INFO-FDA) or visit www.fda.gov/medical-devices/medical-device-recalls.

Your Remedy Options

Other Action

Manufacturer corrective action and technical inspection.

How to: Contact your healthcare provider or the manufacturer for further instructions and potential refund

Affected Products

Product: DxI 9000 Access Immunoassay Analyzer

Model / REF:

REF C11137

UDI/DI 15099590732103

Lot Numbers:

300254

300256

300257

300258

300259

300263

300264

300266

300268

300269

300270

300271

300272

300273

300275

300281

300282

Additional Information

Agency: Food and Drug Administration (FDA)

Event ID: 94191

Status: Active

Manufacturer: Beckman Coulter, Inc.

Sold By: Beckman Coulter, Inc.

Manufactured In: United States

Units Affected: 17 units

Distributed To: New Hampshire

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 · 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.

Summary

What You Should Do

Identify if your laboratory or facility is using the DxI 9000 Access Immunoassay Analyzer (REF C11137) with UDI/DI 15099590732103.

Check the serial number of your unit against the following affected list: 300254, 300256, 300257, 300258, 300259, 300263, 300264, 300266, 300268, 300269, 300270, 300271, 300272, 300273, 300275, 300281, and 300282.

Contact your healthcare provider or Beckman Coulter, Inc. immediately for further instructions regarding inspection and potential equipment repair or replacement.

Report any equipment malfunctions or suspected leaks to the manufacturer to ensure environmental and physical safety.

For additional questions or to report issues, contact the FDA at 1-888-463-6332 (1-888-INFO-FDA) or visit www.fda.gov/medical-devices/medical-device-recalls.