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Medium RiskFDA Device
Medical Devices/Diagnostic Equipment

Beckman Coulter, Inc.: DxI 9000 Access Immunoassay Analyzer Recalled for Tubing Leaks and Data Errors

Agency Publication Date: September 19, 2024
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Summary

Beckman Coulter is recalling 170 units of the DxI 9000 Access Immunoassay Analyzer because of undersized pneumatic tubing in the reagent storage module. This defect can lead to air leaks, compressor failures, and sample processing errors, which may result in incorrect medical test results or significant delays in diagnosis. The company initiated this corrective action after receiving four complaints and discovering the incorrect tubing size in their inventory. This recall affects Model Number C21510 with specific serial numbers distributed worldwide.

Risk

The undersized tubing causes mechanical failures within the reagent storage system, potentially leading to inaccurate diagnostic data or a complete halt in sample processing. Four complaints have been filed regarding this issue, which could lead to medical errors or delayed patient treatment.

What You Should Do

  1. Identify if your facility is using a Beckman Coulter DxI 9000 Access Immunoassay Analyzer (Model Number C21510) by checking the serial number on the device's identification plate.
  2. Verify your device against the affected serial number list, which includes 300116 through 300333 (see Affected Products for the full list of 170 specific numbers).
  3. Check your inventory for RSM Pneumatic Tubing Kit item #2 (REF C11137) with UDI/DI 15099590230623.
  4. Immediately contact Beckman Coulter to schedule a service visit for the installation of the correct tubing kit and to address any compressor or processing errors.
  5. Consult with your healthcare facility's laboratory director regarding any diagnostic results that may have been impacted by device errors during the period the undersized tubing was in use.
  6. For further information or to report issues, contact Beckman Coulter directly or reach out to the FDA at 1-888-463-6332 (1-888-INFO-FDA) or visit www.fda.gov/medical-devices/medical-device-recalls.

Your Remedy Options

You have 2 options:

๐Ÿ”งOption 1: Free Repair

Corrective service actions initiated

How to: Beckman Coulter has initiated corrective actions; contact the manufacturer to coordinate the repair and tubing replacement.
๐Ÿ“‹Option 2: Other Action

Healthcare provider/manufacturer consultation

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

Affected Products

Product: Beckman Coulter DxI 9000 Access Immunoassay Analyzer
Model / REF:
C21510
REF C11137
UPC Codes:
15099590230623
Lot Numbers (170):
Serial Number 300116
Serial Number 300117
Serial Number 300118
Serial Number 300123
Serial Number 300126
Serial Number 300128
Serial Number 300129
Serial Number 300130
Serial Number 300131
Serial Number 300133
Serial Number 300134
Serial Number 300135
Serial Number 300136
Serial Number 300137
Serial Number 300138
Serial Number 300139
Serial Number 300141
Serial Number 300142
Serial Number 300143
Serial Number 300145
Serial Number 300147
Serial Number 300148
Serial Number 300149
Serial Number 300150
Serial Number 300151
Serial Number 300152
Serial Number 300153
Serial Number 300154
Serial Number 300155
Serial Number 300156
Serial Number 300157
Serial Number 300158
Serial Number 300160
Serial Number 300161
Serial Number 300162
Serial Number 300163
Serial Number 300164
Serial Number 300166
Serial Number 300167
Serial Number 300168
Serial Number 300169
Serial Number 300170
Serial Number 300171
Serial Number 300172
Serial Number 300174
Serial Number 300176
Serial Number 300178
Serial Number 300179
Serial Number 300180
Serial Number 300181

Additional Information

Agency: Food and Drug Administration (FDA)
Event ID: 95156
Status: Active
Manufacturer: Beckman Coulter, Inc.
Sold By: Direct from manufacturer; Medical supply distributors
Manufactured In: United States
Units Affected: 170 units
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.