FDAClass IIApril 15, 2020

LabPro Data Management System recall

LabPro Data Management System, UDI: 15099590676872 - Product Usage: The LabPro Data Management System is a Microsoft Windows based software program…

Why was LabPro Data Management System recalled?

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.

What should I do if I have this product?

Review the official FDA enforcement record for current instructions.

What to do with a recalled product: refunds, receipts, safe disposal and how to report a problem.

Is my product affected?

Compare the item in your hand with every identifier below from the official FDA record. Only products that match the listed product and lot, UPC or model codes are part of this recall.

Which lot codes, UPCs or models are affected?

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

Product
LabPro Data Management System, UDI: 15099590676872 - Product Usage: The LabPro Data Management System is a Microsoft Windows based software program…
Recalling firm
Beckman Coulter Inc.
Quantity
177 systems
Distribution
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.
Recall date
April 15, 2020
Classification
Class II
Status
Terminated
Agency
FDA (device)
Open FDA enforcement record Latest recalls