Beckman Coulter Inc. recalls LabPro Data Management System, UDI: 15099590676872 - Product Usage: The LabPro Data Management System is a Microsoft Wi…

Recall date

January 17, 2020

Source

U.S. Food & Drug Administration (FDA) — enforcement report

Recall number

Z-1673-2020

FDA classification

Class II

Brand / firm

Beckman Coulter Inc.

Sold / distributed

Worldwide distribution - US Nationwide distribution in the states of Wisconsin, New York, Delaware, Indiana, Ohio, Tennessee, Florida, Georgia, Illinois, South Carolina, California, New Jersey, Alabama, Massachusetts, Michigan, Texas, West Virginia, Wyoming, Missouri, New Mexico, North Carolina, Mi…

Why it was recalled

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.

Class II means using this product may cause temporary or medically reversible health problems; the chance of serious harm is remote.

What was recalled

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.