Beckman Coulter, Inc.: DxI 9000 Immunoassay Analyzer Recalled for Potential Erroneous Results

Agency Publication Date: October 12, 2023

Summary

Beckman Coulter, Inc. is recalling 36 units of the DxI 9000 Access Immunoassay Analyzer running software version 1.15 and below. The recall was initiated because the device may ignore a sample's barcode and replace it with information from a previous sample in the same position. This software defect can lead to delayed results for current patients and potentially incorrect medical test results for previous patients, which could impact clinical decisions.

Risk

The software error causes the analyzer to associate the test results of a new sample with the identity of a previous patient. This poses a risk of incorrect diagnosis or treatment based on erroneous laboratory data.

What You Should Do

Identify if your laboratory is using the DxI 9000 Access Immunoassay Analyzer (REF C11137) by checking the model name on the device.
Verify the software version currently installed on the system; this recall affects all units running software version 1.15 or lower.
Check the device for Unique Device Identifier (UDI) 15099590732103 to confirm if your specific unit is part of the 36 affected devices.
Contact the manufacturer, Beckman Coulter, Inc., at their Chaska, Minnesota headquarters or through your local service representative for instructions on software updates or corrective actions.
Consult with your healthcare provider or laboratory director regarding any test results processed on affected machines to determine if re-testing is necessary.
For additional questions, contact the FDA at 1-888-463-6332 or visit www.fda.gov/medical-devices/medical-device-recalls.

Your Remedy Options

Other Action

Manufacturer Investigation and Notification

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

UPC Codes:

15099590732103

Lot Numbers:

Software Versions 1.15 and below

Additional Information

Agency: Food and Drug Administration (FDA)

Event ID: 93023

Status: Active

Manufacturer: Beckman Coulter, Inc.

Sold By: Beckman Coulter, Inc.

Manufactured In: United States

Units Affected: 36 units

Distributed To: Florida

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 is using the DxI 9000 Access Immunoassay Analyzer (REF C11137) by checking the model name on the device.

Verify the software version currently installed on the system; this recall affects all units running software version 1.15 or lower.

Check the device for Unique Device Identifier (UDI) 15099590732103 to confirm if your specific unit is part of the 36 affected devices.

Contact the manufacturer, Beckman Coulter, Inc., at their Chaska, Minnesota headquarters or through your local service representative for instructions on software updates or corrective actions.

Consult with your healthcare provider or laboratory director regarding any test results processed on affected machines to determine if re-testing is necessary.

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