—#179968

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.

FDA product code: OUG — Medical Device Data System
Device class: Class 1
Medical specialty: General Hospital
Affected lot / code info: Computers with Remote Diagnostics (Axeda) enabled and Windows 7 operating system.

Why it was 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.

Root cause (FDA determination)

Software Manufacturing/Software Deployment

Action the firm took

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

Recalling firm

Firm: Beckman Coulter Inc.
Address: 250 S Kraemer Blvd, Brea, California 92821-6232

Distribution

Distribution pattern: 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.

Timeline

Recall initiated: 2020-01-17
Terminated: 2021-04-27
Status: —

Source: openFDA Device Recall endpoint. Recall record ID #179968. The FDA issues recall classifications as health-hazard assessments, not legal findings; for legal claims consult a licensed attorney.