Public recall detail

Dxc 500i Clinical Analyzer and Dxc 500 AU Clinical Chemistry Analyzer

2026-09-10

medium
Health products Health product recall
Quick summary

Quick summary: Dxc 500i Clinical Analyzer and Dxc 500 AU Clinical Chemistry Analyzer. Reason: Health product recall. Category: Health products. Date: 2026-09-10.

Recommended action

Recommended action: compare your product with the official notice and follow the instructions published by the official source.

Recall details

Quick summary: Dxc 500i Clinical Analyzer and Dxc 500 AU Clinical Chemistry Analyzer. Reason: Health product recall. Category: Health products. Date: 2026-09-10.

Official details

Affected product details

Structured information extracted from the official recall notice. Confirm the identifiers and instructions in the original notice.

BrandBECKMAN COULTER, INC.
ProductDxc 500i Clinical Analyzer and Dxc 500 AU Clinical Chemistry Analyzer
IssueMedical devices - Performance
Recall classType II
IdentificationRA-82613

Affected products

ProductDxc 500i Clinical Analyzer
LotSoftware V. 1.3.5 or earlier
ModelC63521
Serial numberSoftware V. 1.3.5 or earlier
DescriptionDxc 500i Clinical Analyzer
ProductDxc 500i Clinical Analyzer
LotSoftware V. 1.3.5 or earlier
ModelC63522
Serial numberSoftware V. 1.3.5 or earlier
DescriptionDxc 500i Clinical Analyzer
ProductDxc 500 AU Clinical Chemistry Analyzer
LotSoftware V. 1.4.5 or earlier
ModelC63520
Serial numberSoftware V. 1.4.5 or earlier
DescriptionDxc 500 AU Clinical Chemistry Analyzer
ProductDxc 500 AU Clinical Chemistry Analyzer
LotSoftware V. 1.4.5 or earlier
ModelC63519
Serial numberSoftware V. 1.4.5 or earlier
DescriptionDxc 500 AU Clinical Chemistry Analyzer

Issue

Beckman Coulter identified a software issue affecting DxC 500i and DxC 500 AU Analyzers when testing plasma samples. Following user configuration of a chemistry test to nondefault units, subsequent activation of a draft configuration in the system configuration page may revert units to the system default without notifying the user.

What you should do

  • Contact the manufacturer if you require additional information.
Additional official information
AudienceHealthcare Industry
CategoryHealth products - Medical devices - Chemistry
CompaniesBeckman Coulter, Inc. 250 S. Kraemer Blvd., Brea, California, United States, 92821
Recall date2026-08-26
Published byHealth Canada
Recall classType II
Alert / recall typeHealth product recall
Identification numberRA-82613
Background{}
CompaniesBeckman Coulter, Inc. 250 S. Kraemer Blvd., Brea, California, United States, 92821
AudiencesHealthcare Industry
Source updated2026-09-10

Contains information licensed under the Open Government Licence – Canada. SafetyPulse is independent of the Government of Canada.

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