Recall Z-0492-2020

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) .

FDA-determined 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.