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U.S. Department of Health and Human Services

Class 2 Device Recall AutoMate 2500 Family

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  Class 2 Device Recall AutoMate 2500 Family see related information
Date Initiated by Firm January 19, 2018
Create Date March 22, 2018
Recall Status1 Open3, Classified
Recall Number Z-1169-2018
Recall Event ID 79006
Product Classification Calculator/data processing module, for clinical use - Product Code JQP
Product AutoMate 1200 Catalog Number ODL25120;
AutoMate 1250 Catalog Number ODL25125;
AutoMate 2500 Catalog Number ODL25250;
AutoMate 2550 Catalog Number ODL25255
Code Information All systems up to the following Serial Numbers: ODL25120 Revision T; SN3101, ODL25125 Revision W; SN1508, ODL25250 Revision T; SN2416, ODL25255 Revision W; SN4617
Recalling Firm/
Manufacturer
Beckman Coulter Inc.
250 S Kraemer Blvd
Brea CA 92821-6232
For Additional Information Contact Customer Service
469-961-4941
Manufacturer Reason
for Recall
Belts on the x-axis (and on the y-axis, to a lesser extent) manufactured from 2015 are showing premature failure, posing the remote risk of cross-contamination.
FDA Determined
Cause 2
Device Design
Action Beckman Coulter plans to replace the belt via Service Modification during the next planned service maintenance visit. At that time, the customer will be informed of the belt replacement by the service engineer.
Quantity in Commerce 98 units in the US
Distribution Australia, Austria, Belarus, Belgium, Bosnia and Herzegovina, Brazil, Canada, China, Croatia, Cyprus, Czech Republic, Denmark, Finland, France, Germany, Gibraltar, Greece, Hong Kong, Hungary, India, Ireland, Israel, Italy, Korea, Kuwait, Latvia, Lithuania, Macao, Mayotte, Mexico, Netherlands, New Zealand, Norway, Panama, Poland, Portugal, Qatar, Russia, Saudi Arabia, Singapore, Slovakia, Slovenia, South Africa, Spain, Sweden, Switzerland, Taiwan, Turkey, United Kingdom, United States
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 The manufacturer has initiated the recall and not all products have been corrected or removed. This record will be updated as the status changes.
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