HIGH

Beckman Coulter Recalls DxC 500i Analyzer Modules Over Processing Delays

Beckman Coulter recalled 116 DxC 500i Clinical Analyzer modules on August 4, 2025, due to potential processing delays. The defect may impact the accuracy of test results when ordering certain tests simultaneously. Healthcare providers and patients must stop using the device immediately and follow recall instructions.

Quick Facts at a Glance

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

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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Product Details

The recalled modules include the DxC 500 AU Module w/ISE, REF: C63522, and DxC 500 AU Module, Without ISE, REF: C6352. The affected models were distributed internationally to various countries.

The Hazard

The defect may cause Clinical Chemistry test samples to remain marked as 'In Progress' without errors when ordered simultaneously with Immunoassay tests. This issue can lead to significant processing delays, impacting patient care.

What to Do

Patients and healthcare providers should stop using the affected devices immediately. Contact Beckman Coulter Inc. or your healthcare provider for further instructions and follow the recall notification method provided.

Contact Information

For assistance, call Beckman Coulter Inc. at 1-800-XXX-XXXX or visit their website at https://www.accessdata.fda.gov/scripts/enforcement/enforce_rpt-Product-Tabs.cfm?recall_number=Z-0032-2026.

Key Facts

  • 116 units recalled
  • Affected models: C63522 and C6352
  • International distribution including Poland, India, and Germany
  • Class II recall
  • Stop using the device immediately

Safety Guide

Not sure what to do next? Our guide walks you through the process step by step.

Read: What to Do When You Find a Recalled Product

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Safety Assessment

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

Product Classification

Product TypeClinical Analyzer Module
Sold At
Multiple Retailers

Product Details

Model Numbers
REF/UDI-DI: C63522/14987666545089
C63521/14987666545072. Software Versions: SW 1.3.3 and 1.3.4
Report Date
October 8, 2025
Recall Status
ACTIVE

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