Public recall detail

DxC 500 AU Clinical Chemistry Analyzer

2025-03-06

medium
Recall Safety notice
Quick summary

Quick summary: DxC 500 AU Clinical Chemistry Analyzer. Date: 2025-03-06.

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 500 AU Clinical Chemistry Analyzer. Date: 2025-03-06.

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 500 AU Clinical Chemistry Analyzer
IssueMedical devices - Performance
Recall classType II
IdentificationRA-77067

Affected products

ProductDxC 500 AU Clinical Chemistry Analyzer
Lot2024070118
ModelC63520 C63519
Serial number2024070118
DescriptionDxC 500 AU Clinical Chemistry Analyzer

Issue

Beckman Coulter has determined that the system cannot recalculate a calculated result when results are rerun within the calculated test. The system will report only the calculated result using the initial constituent tests' results to the operator and lis/middleware. A patient may receive unnecessary treatment or testing; or patient treatment may be delayed. Recall Start Date: February 13, 2025

What you should do

  • Contact the manufacturer if you require additional information.
Additional official information
AudienceHealthcare
CategoryHealth products - Medical devices - Chemistry
CompaniesBeckman Coulter, Inc. 250 S. Kraemer Blvd., Brea, California, United States, 92821
Published byHealth Canada
Recall classType II
Alert / recall typeHealth product recall
Identification numberRA-77067
Background{}
CompaniesBeckman Coulter, Inc. 250 S. Kraemer Blvd., Brea, California, United States, 92821
AudiencesHealthcare
Source updated2025-03-06

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

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