Beckman Coulter Inc. recalls AutoMate 1250, Sorter with Aliquot Module - UDI: 15099590364106; Model #ODL25125 Automate 2550, High Speed Sorter with…

Recall date

November 9, 2018

Source

U.S. Food & Drug Administration (FDA) — enforcement report

Recall number

Z-0492-2020

FDA classification

Class II

Brand / firm

Beckman Coulter Inc.

Sold / distributed

US: NY, VA OUS: Austria Belgium Czech Republic France Germany Israel Italy Lithuania Mayotte Romania Slovakia South Africa Spain Sweden Switzerland United Kingdom

Why it was recalled

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) .

Class II means using this product may cause temporary or medically reversible health problems; the chance of serious harm is remote.

What was recalled

AutoMate 1250, Sorter with Aliquot Module - UDI: 15099590364106; Model #ODL25125 Automate 2550, High Speed Sorter with Aliquot Module - UDI: 15099590364083 , Model #ODL25255