Recall Z-0768-2017 ยท OUG Medical Device Data System
Beckman Coulter Inc.
MicroScan LabPro Data Management System. 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 | Dec 15, 2016 (initiated Oct 25, 2016) |
| Status | Terminated |
| Reason | Beckman Coulter has received and confirmed reports of an intermittent and unexpected behavior when loading new panels into a WalkAway instrument using LabPro Data Management System version 4.42. The issue could cause workflow interruption with a potential of delaying reporting results due to the inability to begin processing new panels. |
| Root cause | Device Design |
| Action | An Urgent Medical Device Recall letter dated 10/25/16 was sent to all their customers to inform them that Beckman Coulter has received and confirmed reports of an intermittent and unexpected behavior when loading new panels into a WalkAway instrument using LabPro Data Management System version 4.42. Customers are informed that the issue could cause WalkAway workflow interruption with a potential of delaying reporting results due to the inability to begin processing new panels. The letter informs the customers of the actions to be taken and the resolution for the product on recall. Customers |
| Quantity | 131 units total (130 units in US) |
| Distribution | Worldwide Distribution -- United States and Mexico. |
| FDA record | Open on fda.gov |
510(k) clearances named in this recall
This recall record lists no 510(k) number.