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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 Clinical Chemistry Analyzer Recalled for Barcode Errors

Agency Publication Date: April 25, 2025
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Summary

Beckman Coulter Inc. is recalling 136 units of the DxC 500 AU Clinical Chemistry Analyzer due to software errors that cause incorrect sample barcode identification and processing issues. This automated laboratory equipment is used to measure analytes in patient samples. The recall affects systems running software versions V1.3 through V1.4.3, which may report erroneous or delayed results. No incidents or injuries have been reported at this time.

Risk

The identification and processing errors can lead to laboratories reporting incorrect or delayed diagnostic results. This may cause healthcare providers to make incorrect medical decisions or delay necessary patient treatments.

What You Should Do

  1. This recall affects the Beckman Coulter DxC 500 AU Clinical Chemistry Analyzer (catalog numbers C63519 and C63520) running software versions V1.3, V1.4, V1.4.1, V1.4.2, or V1.4.3.
  2. Check the catalog number and serial number on your analyzer's identification label to determine if your system is included in this recall. 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 medical device distributor to arrange for a system correction, replacement, or return.
  4. Call the FDA at 1-888-463-6332 (1-888-INFO-FDA) for additional questions 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 (Catalog C63519)
Variants: Software V1.3, Software V1.4, Software V1.4.1, Software V1.4.2, Software V1.4.3
Model / REF:
C63519
Serial Numbers:
2024090170
2024060094
2024070114
2024090174
2024070118
UDI:
14987666545058

Quantity: 5 systems.

Product: DxC 500 AU Clinical Chemistry Analyzer (Catalog C63520)
Variants: Software V1.3, Software V1.4, Software V1.4.1, Software V1.4.2, Software V1.4.3
Model / REF:
C63520
Serial Numbers (131):
2023060005
2023070009
2023070010
2023090015
2023090016
2023100019
2023100020
2023110022
2024010033
2024010035
2024010036
2024010037
2024010038
2024020041
2024020042
2024020043
2024020045
2024020046
2024020047
2024030049
2024030051
2024030052
2024030053
2024040056
2024040059
2024050064
2024050070
2024050072
2024060075
2024060088
2024060096
2024060101
2024060103
2024060104
2024060106
2024070109
2024070110
2024070111
2024070116
2024070128
2024070129
2024070130
2024070131
2024070132
2024080138
2024080139
2024080142
2024080145
2024080157
2024080159
UDI:
14987666545065

Quantity: 131 systems.

Additional Information

Agency: Food and Drug Administration (FDA)
Event ID: 96483
Status: Active
Manufacturer: Beckman Coulter Inc.
Sold By: Authorized Medical Device Distributors; Direct Sales
Manufactured In: United States
Units Affected: 136 systems (U.S. 68 and O.U.S. 68)
Distributed To: Alabama, California, Colorado, Georgia, Idaho, Illinois, Indiana, Louisiana, Massachusetts, Michigan, Minnesota, Mississippi, Montana, North Carolina, New Mexico, Nevada, New York, Oklahoma, Oregon, Pennsylvania, Puerto Rico, South Carolina, Tennessee, Texas, Washington, Wisconsin

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.