Z-1673-2020 Class II Terminated

Recalled by Beckman Coulter Inc. — Brea, CA

FDA device recall Z-1673-2020 was initiated by Beckman Coulter Inc. on January 17, 2020 and is designated Class II. Reason for recall: 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 Sys… The recall status is terminated (terminated April 27, 2021). Affected quantity: 177 systems.

Recall Details

Product Type
Devices
Report Date
April 15, 2020
Initiation Date
January 17, 2020
Termination Date
April 27, 2021
Voluntary/Mandated
Voluntary: Firm initiated
Product Quantity
177 systems

Product Description

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.

Reason for Recall

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.

Distribution Pattern

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.

Code Information

Computers with Remote Diagnostics (Axeda) enabled and Windows 7 operating system.