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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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High RiskFDA Device
Medical Devices/Diagnostic Equipment

Beckman Coulter DxI 9000 Immunoassay Analyzer Recalled for Motor Misalignment

Agency Publication Date: March 17, 2025
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Summary

Beckman Coulter, Inc. has recalled 206 units of the DxI 9000 Access Immunoassay Analyzer (Catalog Number C11137) because a motor part called the encoder wheel may be misaligned. This defect can cause the machine to stop working or report errors, which creates a high safety risk by delaying critical patient test results. There have been no reported injuries or incidents at the time of this recall.

Risk

The misaligned part causes the instrument to malfunction or stop during testing. This can lead to significant delays in providing medical results to patients, potentially resulting in postponed diagnosis or treatment.

What You Should Do

  1. The recalled product is the DxI 9000 Access Immunoassay Analyzer, Catalog Number C11137, with UDI-DI 15099590732103.
  2. To determine if your analyzer is affected, check the serial number printed on the device identification label. See the Affected Products section below for the full list of affected codes.
  3. Stop using the recalled product. Contact Beckman Coulter, Inc. or your authorized distributor to arrange for a return, replacement, or correction of the instrument.
  4. If you have additional questions regarding this recall, call the FDA at 1-888-463-6332 (1-888-INFO-FDA).

Your Remedy Options

๐Ÿ“‹Other Action
How to: Stop using the recalled product. Contact the manufacturer or your distributor to arrange return, replacement, or correction.

Affected Products

Product: DxI 9000 Access Immunoassay Analyzer
Model / REF:
C11137
Serial Numbers:
300116-300117
300123-300124
300126
300128-300139
300141-300145
300147-300158
300160-300164
300166-300179
300181-300183
300186
300188-300195
300197-300207
300209-300250
300252-300256
300258-300259
300261
300263-300264
300266-300277
300279-300290
300291
300293-300299
300300-300309
300312-300352
UDI:
15099590732103

Units manufactured in the United States.

Additional Information

Agency: Food and Drug Administration (FDA)
Event ID: 96256
Status: Active
Manufacturer: Beckman Coulter, Inc.
Sold By: Direct from manufacturer; Authorized medical device distributors
Manufactured In: United States
Units Affected: 206 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.