Health product recall

Beckman Coulter AU Immunochemistry System - AU480 Analyzer

Last updated

Summary

Product
Beckman Coulter AU Immunochemistry System - AU480 Analyzer
Issue
Medical devices - Performance
What to do

Contact the manufacturer if you require additional information. 

Audience
Healthcare

Affected products

Affected products Lot or serial number Model or catalogue number
Beckman Coulter AU Immunochemistry System - AU480 Analyzer 2021104332 AU480
Beckman Coulter AU Immunochemistry System - AU480 Analyzer 2021124493 AU480
Beckman Coulter AU Immunochemistry System - AU480 Analyzer 2022014627 AU480
Beckman Coulter AU Immunochemistry System - AU480 Analyzer 2021124487 AU480
Beckman Coulter AU Immunochemistry System - AU480 Analyzer 2022014611 AU480

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.

Additional information

Details
Original published date:
Alert / recall type
Health product recall
Category
Health products - Medical devices - Chemistry
Companies
Beckman Coulter, Inc.
250 S. Kraemer Blvd., Brea, California, United States, 92821
Published by
Health Canada
Audience
Healthcare
Recall class
Type II
Recall date
Identification number
RA-82443

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