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Beckman Coulter Inc. recalls LabPro Data Management System, UDI: 15099590676872 - Product Usage: The LabPro Data Management System is a Microsoft Win
Recalled April 15, 2020 · FDA recall Z-1673-2020 · Beckman Coulter
Hazard
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. · FDA Class II
Units
177 systems
Sold at
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, Minnesota, New Hampshire, Oklahoma, Washington, Pennsylvania, Idaho, Mississippi, Maryland, Virginia, Arizona, Utah, Maine, Michigan, Colorado, Iowa, Louisiana, Kentucky, South Dakota, Nevada, North Dakota, Kentucky and countries of Brazil, Germany.
Description
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.
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.
Manufacturer(s)
Beckman Coulter Inc.
Source: U.S. Food and Drug Administration. Official recall notice on fda.gov →