medical Class II Updated 2020-04-15

Beckman Coulter Inc. recalls LabPro Data Management System, UDI: 15099590676872 - Product

Recalled Product

LabPro Data Management System, UDI: 15099590676872 - Product Usage: The LabPro Data Management System is a Microsoft Windows based software program and is intended to manage both microbial identification (ID) and antimicrobial agent susceptibility testing (AST) data generated from MicroScan instruments or manually entered microbiology test results, for use by trained laboratory personnel.


Hazard / Issue

A security-only update was released via remote diagnostics on January 14, 2020 to customers with Windows 7 operation system. Shortly after the releases some customers reported that Data Management System computers would not restart. If the computer is unable to restart, then the system cannot download data generated from MicroScan instruments or manually entered microbiology test results, resulting in a potential of delayed results.

Issued by

FDA

Distribution: Nationwide (United States)
Lot/Code Info: Computers with Remote Diagnostics (Axeda) enabled and Windows 7 operating system.
View official government recall

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