AutoMate 1250, Sorter with Aliquot Module - UDI: 15099590364106; Model #ODL25125 Automate 2550, High Speed Sorter with Aliquot Module - UDI: 15099590364083 , Model #ODL25255
- Company
- Beckman Coulter Inc.
- Recall Initiated
- November 9, 2018
- Recall Number
- Z-0492-2020
- Quantity
- 83 automate systems
- Firm Location
- Brea, CA
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
US: NY, VA OUS: Austria Belgium Czech Republic France Germany Israel Italy Lithuania Mayotte Romania Slovakia South Africa Spain Sweden Switzerland United Kingdom
Lot / Code Info
All units containing software Version(s) 4.1.1 and up
Root Cause
Other
Action Taken
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 prerequisites. 2. Please share this information with your laboratory staff and retain this notification as part of your laboratory Quality System documentation. 3. If you are a centralized license holder, please provide the other affected laboratories of your organization or association with a copy of this letter. 5. Please complete and return the enclosed Response Form within 10 days so we are assured you have received this important communication. 6. If you have any questions regarding this notice, please contact Beckman Coulter via: http://www.beckmancoulter.com; by phone (800) 526-3821, or your local Beckman Coulter representative.