HIGH

Beckman Coulter DxC 500i Clinical Analyzer Modules Recalled for Processing Delays (2025)

Beckman Coulter has issued a recall for 116 DxC 500 AU Module with ISE and DxC 500i components sold internationally. The recall date is 2025-08-04. A processing fault can cause the Clinical Chemistry test to stay In Progress when an Immunoassay test is run between CC tests. Delays may occur. Stop using the device and contact Beckman Coulter for instructions.

Quick Facts at a Glance

Recall Date
August 4, 2025
Hazard Level
HIGH
Brand
Beckman Coulter
Category
Health & Personal Care
Sold At
Unknown
At-Risk Groups
GENERAL, PREGNANT, PETS

Hazard Information

On a clinical analyzer, when ordering a Clinical Chemistry (CC) combination test simultaneously with an Immunoassay (IA) test, if the IA test is processed between the CC tests, CC sample status will remain In Progress with no errors, may cause processing delays.

What You Should Do

Patients and healthcare providers should stop using this device immediately. Follow the recall instructions provided by the manufacturer. Contact Beckman Coulter Inc. or your healthcare provider for instructions. Notification method: Letter

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About This Product

DxC 500i Clinical Analyzer family processes multiple clinical tests including Clinical Chemistry and Immunoassay. The affected modules enable testing on the analyzer.

Why This Is Dangerous

Misordered CC and IA tests can cause CC status to stay In Progress, delaying results without error messages.

Industry Context

This recall is not part of a broader industry pattern.

Real-World Impact

Delays may impact patient care timelines and lab workflows; no injuries or patient harm reported in the recall data.

Practical Guidance

How to identify if yours is affected

  1. Check if your DxC 500 AU Module with ISE or DxC 500i is REF C63522 or C6352.
  2. Verify software versions SW 1.3.3 or 1.3.4.
  3. Review your device purchase and installation dates.

Where to find product info

Manufacturer recall letter and FDA recall page linked in notice.

What timeline to expect

Refunds or replacements are provided per Beckman Coulter notice; handling timelines not specified in data.

If the manufacturer is unresponsive

  • Document all communications with Beckman Coulter.
  • Escalate to hospital risk management or vendor representative if no response within 2 weeks.

How to prevent similar issues

  • Verify test order workflows to minimize cross-test timing.
  • Keep software updated within approved versions.
  • Establish lab protocol for concurrent CC and IA testing.

Documentation advice

Retain recall letter, IT/system logs showing test sequencing, all correspondence with Beckman Coulter.

Product Details

Model numbers include REF/UDI-DI: C63522/14987666545089 and C63521/14987666545072. Software versions affected: SW 1.3.3 and 1.3.4. Distribution countries include Poland, India, Dominican Republic, Lebanon, Italy, Brazil, El Salvador, Saudi Arabia, Germany, France, Nepal, Canada, Chile, Spain, Malaysia, Switzerland, Morocco, Philippines, Curacao, Qatar, United Arab Emirates, Hungary, Czechia, Oman, New Zealand, Thailand, Indonesia, Algeria, United Kingdom, Namibia, Turkey, Republic of Korea.

Reported Incidents

No data on injuries or fatalities is provided in the recall notice.

Key Facts

  • 116 total units recalled
  • DxC 500 AU Module with ISE and DxC 500i components affected
  • Ref: C63522 and C6352
  • Software SW 1.3.3 and 1.3.4
  • International distribution to 30+ countries
  • High hazard level
View Original Recall on FDA - Medical Devices

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Safety Assessment

Risk LevelHIGH
Severity Score
8/ 10
Affected Groups
GENERALPREGNANTPETS
Injury Types
OTHER

Product Classification

Product TypeClinical Analyzer Module
Sold At
Unknown

Product Details

Model Numbers
C63522
C63521
SW 1.3.3
SW 1.3.4
Report Date
October 8, 2025
Recall Status
ACTIVE

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