Recall Z-1673-2020— Beckman Coulter Inc.

Class II FDA medical device recall by Beckman Coulter Inc., initiated 2020-01-17, terminated 2021-04-27. FDA's recall record names no specific 510(k) clearance for this event. 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.. Reason: 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..

Recalling firm

Beckman Coulter Inc.

Classification

Class II

Status

Terminated

Initiated

2020-01-17

Terminated

2021-04-27

Firm location

Brea, CA, United States

Data sourced from openFDA. This site is unofficial and independent of the FDA.