AutoMate 2500 Family Catalog No. ODL25120 AutoMate 1200, ODL25125, AutoMate 1250, ODL25250 AutoMa...
FDA Recall #Z-1040-2017 — Class III — December 21, 2016
Product Description
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 for Recall
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. — Brea, CA
Classification
Class III — Not likely to cause adverse health consequences.
Product Type
Devices
Product Quantity
4 units
Distribution
US Distribution to MD only.
Code Information
ODL25255-4437 ODL25255-4443 ODL25255-4444 ODL25255-4438
Status
Terminated
Voluntary / Mandated
Voluntary: Firm initiated