Recall Z-1040-2017— Beckman Coulter Inc.

Class III FDA medical device recall by Beckman Coulter Inc., initiated 2016-12-21, terminated 2017-05-17. FDA's recall record names no specific 510(k) clearance for this event. Product: 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.. Reason: Beckman Coulter initiated a design change to update the Automate PC image to accommodate the operating system change to Windows 10..

Recalling firm

Beckman Coulter Inc.

Classification

Class III

Status

Terminated

Initiated

2016-12-21

Terminated

2017-05-17

Firm location

Brea, CA, United States

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