Device product
AutoMate 1250, Sorter with Aliquot Module - UDI: 15099590364106; Model #ODL25125 Automate 2550, High Speed Sorter with Aliquot Module - UDI: 15099590364083 , Model #ODL25255
Z-0492-2020
Product summary
- Event
- Event 83732
- Status
- Ongoing
- Classification
- Class II
- Quantity
- 83 automate systems
- Official record key
device-enforcement:Z-0492-2020
Official wording
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) .
Code information: All units containing software Version(s) 4.1.1 and up
Distribution pattern: US: NY, VA OUS: Austria Belgium Czech Republic France Germany Israel Italy Lithuania Mayotte Romania Slovakia South Africa Spain Sweden Switzerland United Kingdom
Derived failure modes
-
Unknown
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) .