Z-0492-2020 Class II Ongoing
Recall Details
- Product Type
- Devices
- Report Date
- November 27, 2019
- Initiation Date
- November 9, 2018
- Termination Date
- N/A
- Voluntary/Mandated
- Voluntary: Firm initiated
- Product Quantity
- 83 automate systems
Product Description
AutoMate 1250, Sorter with Aliquot Module - UDI: 15099590364106; Model #ODL25125 Automate 2550, High Speed Sorter with Aliquot Module - UDI: 15099590364083 , Model #ODL25255
Reason for Recall
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) .
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
Code Information
All units containing software Version(s) 4.1.1 and up