Company: Beckman Coulter Inc.
Date of Enforcement Report: 4/15/2020
Class II
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.
- Recall Number: Z-1673-2020
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/MANUFACTURER
Beckman Coulter Inc. on 1/17/2020. Voluntary: Firm Initiated recall is ongoing.
VOLUME OF PRODUCT IN COMMERCE
177 systems
DISTRIBUTION
US Nationwide and International