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U.S. Department of Health and Human Services

Class 2 Device Recall LabPro Data Management System

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  Class 2 Device Recall LabPro Data Management System see related information
Date Initiated by Firm January 17, 2020
Create Date April 06, 2020
Recall Status1 Terminated 3 on April 27, 2021
Recall Number Z-1673-2020
Recall Event ID 85048
Product Classification Medical device data system - Product Code OUG
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.
Code Information Computers with Remote Diagnostics (Axeda) enabled and Windows 7 operating system.
Recalling Firm/
Manufacturer		 Beckman Coulter Inc.
250 S Kraemer Blvd
Brea CA 92821-6232
For Additional Information Contact Jose Untalan
916-374-3031
Manufacturer 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.
FDA Determined
Cause 2		 Software Manufacturing/Software Deployment
Action On January 17, 2020 Beckman Coulter sent an "Urgent Medical Device Recall" email to all affected customers. In addition to informing customers about the recall they asked customers to take the following action: If you have received a prompt to restart the LabPro computer on or after January 14, 2020 and have not yet restarted the computer, then do not restart the computer and you will be contacted by your Beckman Coulter Representative for further instructions. If you are unsure if you have received the restart prompt, then monitor the LabPro computer for at least an hour to see if the restart prompt appears. The prompt will redisplay hourly, if prompted, do not restart the computer. If you have received a prompt to restart the LabPro computer on or after January 14, 2020, and successfully restarted the computer, then no further action is required. Please share this information with your laboratory staff and retain this notification as part of your laboratory Quality System documentation. If you have forwarded any of the affected products listed above to another laboratory, please provide them a copy of this letter. In order to assure you have received this important communication, please respond within 10 days in one of the following ways: - Electronically, if you received this communication via email. - Manually, complete and return the enclosed Response Form. If you have any questions regarding this notice, please contact our Customer technical Support Center: - Via our website, http://www.beckmancoulter.com/customersupport/support - Via phone, call 1-800-677-7226 in the United States - If outside the United STates, please contact your local Beckman Coulter Representative
Quantity in Commerce 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.
Total Product Life Cycle TPLC Device Report
1 A record in this database is created when a firm initiates a correction or removal action. The record is updated if the FDA identifies a violation and classifies the action as a recall, and it is updated for a final time when the recall is terminated. Learn more about medical device recalls.
2 Per FDA policy, recall cause determinations are subject to modification up to the point of termination of the recall.
3 For details about termination of a recall see Code of Federal Regulations (CFR) Title 21 §7.55.
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