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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.: Dxl 9000 Access Immunoassay Analyzers Recalled for Corroding USB Cables

Agency Publication Date: July 23, 2024
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Summary

Beckman Coulter, Inc. is recalling 143 units of the Dxl 9000 Access Immunoassay Analyzer (Catalog #C11137) because they were manufactured with incorrect USB cables. These cables utilize brass contacts instead of the required gold contacts, which are prone to corrosion over time. This defect can cause the analyzer to lose internal communication, resulting in failures and significant delays in providing patient test results.

Risk

The use of brass instead of gold in the USB cable contacts leads to chemical corrosion. If the contacts corrode, the instrument's internal components cannot communicate effectively, which may stop the device from functioning and cause delays in medical diagnosis or treatment.

What You Should Do

  1. Identify if you have a Dxl 9000 Access Immunoassay Analyzer by checking for Catalog #C11137 on the device labeling.
  2. Verify if your device's serial number is among the 143 affected units, which include serials 300117, 300116, 300137, 300138, 300139, 300129, 300141, 300143, 300142, 300151, 300152, 300128, 300156, 300153, 300154, 300135, 300164, 300180, 300155, 300167, 300166, 300158, 300171, 300179, 300169, 300182, 300176, 300183, 300198, 300192, 300133, 300188, 300161, 300134, 300190, 300209, 300212, 300211, 300149, 300148, 300150, 300130, 300172, 300197, 300160, 300189, 300170, 300181, 300195, 300194, 300224, 300222, 300168, 300210, 300233, 300207, 300205, 300221, 300203, 300240, 300199, 300200, 300136, 300196, 300178, 300220, 300208, 300126, 300213, 300206, 300219, 300214, 300217, 300215, 300229, 300255, 300257, 300202, 300254, 300223, 300258, 300259, 300218, 300201, 300234, 300237, 300249, 300260, 300238, 300243, 300261, 300231, 300191, 300131, 300236, 300264, 300263, 300193, 300239, 300230, 300235, 300245, 300216, 300247, 300242, 300226, 300270, 300271, 300269, 300174, 300251, 300241, 300232, 300204, 300227, 300228, 300256, 300266, 300281, 300282, 300253, 300244, 300272, 300246, 300145, 300123, 300147, 300297, 300157, 300275, 300284, 300286, 300248, 300273, 300252, 300144, 300146, 300165, 300177, 300173, 300250, 300268, and 300140.
  3. If your serial number is on the list, contact Beckman Coulter, Inc. to acknowledge receipt of the notification and to schedule the necessary repair or cable replacement.
  4. Direct any clinical questions regarding delayed results to your healthcare provider.
  5. For more information, contact Beckman Coulter, Inc. or call the FDA at 1-888-463-6332 (1-888-INFO-FDA).

Your Remedy Options

๐Ÿ“‹Other Action

Manufacturer Repair and Guidance

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

Affected Products

Product: Dxl 9000 Access Immunoassay Analyzer
Model / REF:
Catalog #C11137
UPC Codes:
15099590732103
Lot Numbers (143):
300117
300116
300137
300138
300139
300129
300141
300143
300142
300151
300152
300128
300156
300153
300154
300135
300164
300180
300155
300167
300166
300158
300171
300179
300169
300182
300176
300183
300198
300192
300133
300188
300161
300134
300190
300209
300212
300211
300149
300148
300150
300130
300172
300197
300160
300189
300170
300181
300195
300194

Additional Information

Agency: Food and Drug Administration (FDA)
Event ID: 94847
Status: Active
Manufacturer: Beckman Coulter, Inc.
Sold By: Beckman Coulter, Inc. authorized distributors; Direct healthcare facility sales
Manufactured In: United States
Units Affected: 143 devices
Distributed To: Florida, Indiana, Kansas, New Hampshire, 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.