Public recall detail

Beckman Coulter AU Immunochemistry System - AU480 Analyzer

2026-08-06

medium
Health products Health product recall
Quick summary

Quick summary: Beckman Coulter AU Immunochemistry System - AU480 Analyzer. Reason: Health product recall. Category: Health products. Date: 2026-08-06.

Recommended action

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

Recall details

Quick summary: Beckman Coulter AU Immunochemistry System - AU480 Analyzer. Reason: Health product recall. Category: Health products. Date: 2026-08-06.

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.
ProductBeckman Coulter AU Immunochemistry System - AU480 Analyzer
IssueMedical devices - Performance
Recall classType II
IdentificationRA-82443

Affected products

ProductBeckman Coulter AU Immunochemistry System - AU480 Analyzer
Lot2021104332
ModelAU480
Serial number2021104332
DescriptionBeckman Coulter AU Immunochemistry System - AU480 Analyzer
ProductBeckman Coulter AU Immunochemistry System - AU480 Analyzer
Lot2021124493
ModelAU480
Serial number2021124493
DescriptionBeckman Coulter AU Immunochemistry System - AU480 Analyzer
ProductBeckman Coulter AU Immunochemistry System - AU480 Analyzer
Lot2022014627
ModelAU480
Serial number2022014627
DescriptionBeckman Coulter AU Immunochemistry System - AU480 Analyzer
ProductBeckman Coulter AU Immunochemistry System - AU480 Analyzer
Lot2021124487
ModelAU480
Serial number2021124487
DescriptionBeckman Coulter AU Immunochemistry System - AU480 Analyzer
ProductBeckman Coulter AU Immunochemistry System - AU480 Analyzer
Lot2022014611
ModelAU480
Serial number2022014611
DescriptionBeckman Coulter AU Immunochemistry System - AU480 Analyzer

Issue

Beckman Coulter has determined that a software defect in AU480 chemistry analyzers using Microsoft® SQL server 2022 express may cause a DB connection error that renders alarmDB unreadable and prevents instrument startup. The issue is associated with transaction log auto-growth, and may cause delays in reporting patient test results to physicians.

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
Recall date2026-08-03
Published byHealth Canada
Recall classType II
Alert / recall typeHealth product recall
Identification numberRA-82443
Background{}
CompaniesBeckman Coulter, Inc.250 S. Kraemer Blvd., Brea, California, United States, 92821
AudiencesHealthcare
Source updated2026-08-06

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

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