The Recall Desk
ModerateFDA (Devices)·Z-1673-2020·Announced 2020-04-15

Beckman Coulter LabPro Data Management System Software Update Recall

Beckman Coulter is recalling 177 LabPro Data Management Systems because a security update caused some computers to fail to restart, potentially delaying microbiology test results.

What this means for you

Minor labeling or packaging issue, or a voluntary precautionary recall. Risk of harm is low but real — follow the manufacturer's instructions.

Our severity reasoning: The recall is classified as FDA Class II. The hazard involves a software malfunction causing delayed test results rather than direct physical injury or death, fitting the criteria for moderate severity.

Plain-English summary

Beckman Coulter Inc. is recalling 177 units of the LabPro Data Management System. This software program is used by trained laboratory personnel to manage microbial identification and antimicrobial agent susceptibility testing data generated from MicroScan instruments or manually entered results.

The recall was initiated after a security-only update was released via remote diagnostics on January 14, 2020, to customers using the Windows 7 operating system. Following the release, some customers reported that their Data Management System computers would not restart. If a computer is unable to restart, the system cannot download data, which results in a potential delay in microbiology test results.

The affected systems were distributed worldwide, including nationwide distribution across numerous US states and in Brazil and Germany. The specific units affected are computers with Remote Diagnostics (Axeda) enabled and the Windows 7 operating system. Affected customers should contact Beckman Coulter for further instructions on resolving the restart issue.

The recalled product

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 fro
Affected units
177

Distribution

Distributed nationwide across the United States.

The notice also names 40 states specifically: