Recall Z-0492-2020— Beckman Coulter Inc.

Name: FDA recall Z-0492-2020
Creator: U.S. Food and Drug Administration
Published: 2018-11-09

Class II · Ongoing

Class II FDA medical device recall by Beckman Coulter Inc., initiated 2018-11-09. FDA's recall record names no specific 510(k) clearance for this event. Product: AutoMate 1250, Sorter with Aliquot Module - UDI: 15099590364106; Model #ODL25125 Automate 2550, High Speed Sorter with Aliquot Module - UDI: 15099590364083 , Model #ODL25255. 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) ..

Recalling firm: Beckman Coulter Inc.
Classification: Class II
Status: Ongoing
Initiated: 2018-11-09
Firm location: Brea, CA, United States

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) .

Data sourced from openFDA. This site is unofficial and independent of the FDA.