Beckman Coulter Inc. recalls AutoMate 2500 Family Catalog No. ODL25120 AutoMate 1200, ODL25125, AutoMate 1250, ODL25250 AutoMate 2500, ODL25255 Auto…

Recall date

December 21, 2016

Source

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

Recall number

Z-1040-2017

FDA classification

Class III

Brand / firm

Beckman Coulter Inc.

Sold / distributed

US Distribution to MD only.

Why it was recalled

Beckman Coulter initiated a design change to update the Automate PC image to accommodate the operating system change to Windows 10.

Class III means the product violates regulations but is not likely to cause harm.

What was recalled

AutoMate 2500 Family Catalog No. ODL25120 AutoMate 1200, ODL25125, AutoMate 1250, ODL25250 AutoMate 2500, ODL25255 Automate 2550. AutoMate 1200/1250/2500/2550 System Series is a semi-open, pre- and post-analytical sample processing and sorting system. The base system automates the sample sorting, decapping, and archiving process. Handling and sorting of samples includes automatic detection of the tube type and cap type (color). Optional features include an Aliquot Module for creation of labeled secondary tubes (including detection of the presence of adequate volume for the requested aliquots) and a Recapper Module to re-seal previously decapped tubes prior to archiving.