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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 DxC 500 AU Analyzers Recalled for Inaccurate Test Results

Agency Publication Date: February 25, 2025
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Summary

Beckman Coulter has recalled approximately 56 DxC 500 AU Clinical Chemistry Analyzers because a software defect can cause the machines to use expired testing chemicals (assays). This error happens when the system's software is upgraded while assays are already loaded, leading the machine to display incorrect expiration dates. No injuries or incidents have been reported to date, but the company initiated this voluntary recall to prevent medical errors.

Risk

If the analyzer uses expired chemicals for testing, it may produce inaccurate or erroneous lab results. These incorrect results could lead healthcare providers to make improper diagnosis or treatment decisions for patients.

What You Should Do

  1. This recall affects DxC 500 AU Clinical Chemistry Analyzers (models C63519 and C63520) running software versions V1.4, V1.4.1, V1.4.2, or V1.4.3.
  2. Check the serial number on your analyzer's label to determine if your unit is affected. See the Affected Products section below for the full list of affected codes.
  3. Stop using the recalled product and do not process patient samples if your instrument was upgraded while assays were loaded.
  4. Contact Beckman Coulter direct sales or your medical device distributor to arrange for a software correction or for further instructions on managing onboard stability dates.
  5. Call the FDA at 1-888-463-6332 (1-888-INFO-FDA) for additional information regarding this recall.

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: DxC 500 AU Clinical Chemistry Analyzer (REF: C63519)
Variants: Software Version V1.4, Software Version V1.4.1, Software Version V1.4.2, Software Version V1.4.3
Model / REF:
C63519
Serial Numbers:
2024090170
UDI:
14987666545058

Recall #: Z-1233-2025

Product: DxC 500 AU Clinical Chemistry Analyzer (REF: C63520)
Variants: Software Version V1.4, Software Version V1.4.1, Software Version V1.4.2, Software Version V1.4.3
Model / REF:
C63520
Serial Numbers (55):
2024070116
2023070009
2024010038
2024010035
2024050072
2024040056
2024030049
2024020046
2024070111
2024030051
2024030052
2024010033
2023090015
2024060103
2024060104
2024060101
2024080145
2024020045
2024020042
2024020043
2024020047
2024060096
2024040059
2023100019
2024030053
2023070010
2024070129
2024070130
2024020041
2024090183
2024010036
2024010037
2024070132
2024070131
2023100020
2024050064
2024050070
2023090016
2023110022
2024070110
2024060075
2024060106
2023110023
2024010024
2024010025
2024050066
2024010029
2024060107
2023080012
2024040060
UDI:
14987666545065

Recall #: Z-1233-2025

Additional Information

Agency: Food and Drug Administration (FDA)
Event ID: 96193
Status: Active
Manufacturer: BECKMAN COULTER LABORATORY SYSTEMS (SUZHOU) CO., LTD.
Sold By: Beckman Coulter direct sales; Medical device distributors
Manufactured In: China
Units Affected: 56
Distributed To: Massachusetts, California, South Carolina, Louisiana, Oklahoma, Georgia, Alabama, Texas, Oregon, Idaho, Colorado, Minnesota, New York, Mississippi, Pennsylvania, Washington, Illinois, Michigan, Puerto Rico

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.