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U.S. Department of Health and Human Services

Class 3 Device Recall AutoMate 2500 Family SampleProcessing System

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  Class 3 Device Recall AutoMate 2500 Family SampleProcessing System see related information
Date Initiated by Firm December 21, 2016
Date Posted January 18, 2017
Recall Status1 Terminated 3 on May 17, 2017
Recall Number Z-1040-2017
Recall Event ID 76054
Product Classification Calculator/data processing module, for clinical use - Product Code JQP
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.
Code Information ODL25255-4437 ODL25255-4443 ODL25255-4444 ODL25255-4438 
Recalling Firm/
Manufacturer		 Beckman Coulter Inc.
250 S Kraemer Blvd
Brea CA 92821-6232
Manufacturer Reason
for Recall		 Beckman Coulter initiated a design change to update the Automate PC image to accommodate the operating system change to Windows 10.
FDA Determined
Cause 2		 Under Investigation by firm
Action The firm, Beckman Coulter, initiated a cite visit to correct the 4 systems installed. The firm will perform the correction by Field Service and tracked via Service Modification. If you have any questions, contact the VP, Global Quality Systems & Compliance at 714-961-4933 or email: RegulatoryAgencyInquiries@beckman.com.
Quantity in Commerce 4 units
Distribution US Distribution to MD only.
Total Product Life Cycle TPLC Device Report
1 A record in this database is created when a firm initiates a correction or removal action. The record is updated if the FDA identifies a violation and classifies the action as a recall, and it is updated for a final time when the recall is terminated. Learn more about medical device recalls.
2 Per FDA policy, recall cause determinations are subject to modification up to the point of termination of the recall.
3 For details about termination of a recall see Code of Federal Regulations (CFR) Title 21 §7.55.
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