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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 Mishima K.K.: DxC 500 AU Clinical Chemistry Analyzer Recalled for Software Issue

Agency Publication Date: August 21, 2024
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Summary

Beckman Coulter Mishima K.K. is recalling 24 DxC 500 AU Clinical Chemistry Analyzers due to a software error that occurs after the machine processes 250 sample racks. This defect causes the instrument to hold samples requiring a rerun or reflex test in a buffer area and report an error code '9000'. This issue can lead to significant delays in providing critical medical test results to patients. If you use this analyzer, contact the manufacturer to address the software problem.

Risk

The software defect causes samples to be held without processing after a specific threshold is reached, which may delay clinical results and potentially impact patient care decisions that rely on timely diagnostic data.

What You Should Do

  1. Identify if your laboratory is using the DxC 500 AU Clinical Chemistry Analyzer (Catalog Number C63520) by checking the UDI-DI code 14987666545065.
  2. Verify if your device's serial number is among the 24 affected units: 2023070010, 2023060005, 2023090015, 2023070009, 2023080011, 2023080012, 2023100019, 2023100018, 2023100020, 2024010037, 2024010036, 2023110022, 2024010038, 2023090016, 2024020040, 2024020041, 2024020039, 2024020043, 2024020042, 2023110023, 2024020045, 2024020046, 2024010024, or 2024010025.
  3. If your analyzer reports error code '9000' and holds racks in the Sample Handler's Buffer, be aware that results for those samples will be delayed.
  4. Contact your healthcare provider or Beckman Coulter Mishima K.K. for technical support, software updates, and further instructions regarding the 250-rack cumulative limit.
  5. For additional questions, 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

๐Ÿ“‹Other Action

Software issue resolution and delay management

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

Affected Products

Product: DxC 500 AU Clinical Chemistry Analyzer
Model / REF:
C63520
Lot Numbers:
14987666545065
2023070010
2023060005
2023090015
2023070009
2023080011
2023080012
2023100019
2023100018
2023100020
2024010037
2024010036
2023110022
2024010038
2023090016
2024020040
2024020041
2024020039
2024020043
2024020042
2023110023
2024020045
2024020046
2024010024
2024010025

Additional Information

Agency: Food and Drug Administration (FDA)
Event ID: 95018
Status: Active
Manufacturer: Beckman Coulter Mishima K.K.
Sold By: Beckman Coulter; Direct distribution to clinical laboratories
Manufactured In: Japan
Units Affected: 24 analyzers
Distributed To: Alabama, California, Georgia, Hawaii, Illinois, Michigan, Minnesota, Mississippi, Nebraska, New York, Oregon, Pennsylvania, South Carolina

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.