Recall Z-1673-2020 ยท OUG Medical Device Data System
Beckman Coulter Inc.
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.
| Date | Jan 17, 2020 |
| Status | Terminated |
| 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. |
| Root cause | 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 rest |
| 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, Min |
| FDA record | Open on fda.gov |
510(k) clearances named in this recall
This recall record lists no 510(k) number.