Recall Z-0492-2020 ยท JQP Calculator/Data Processing Module, For Clinical Use
Beckman Coulter Inc.
AutoMate 1250, Sorter with Aliquot Module - UDI: 15099590364106; Model #ODL25125 Automate 2550, High Speed Sorter with Aliquot Module - UDI: 15099590364083 , Model #ODL25255
| Date | Nov 9, 2018 |
| Status | Open, Classified |
| Reason | Beckman Coulter has identified a case where a customer using the microltiterplate kit option without a sorting drive encountered a cross-contamination of samples when a connection time-out occurred between the system and Laboratory Information System (LIS) . |
| Root cause | Other |
| Action | A "Urgent Medical device Recall" letter was sent to affected consignees on November 9, 2018 via USPS. The letter informed consignees of the following: 1. If you are using the MTP kit option of the AutoMate 2500 Family systems, please ensure that your system meets the required software prerequisites stated in the Issue section. " If the requirements are met, you can safely continue using your system. " If the requirements are not met; Permanently discontinue using the MTP kit option or Contact your Beckman Coulter representative to upgrade your system to meet the required software prerequis |
| Quantity | 83 automate systems |
| Distribution | US: NY, VA OUS: Austria Belgium Czech Republic France Germany Israel Italy Lithuania Mayotte Romania Slovakia South Africa Spain Sweden Switzerland United Kingdom |
| FDA record | Open on fda.gov |
510(k) clearances named in this recall
This recall record lists no 510(k) number.