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U.S. Department of Health and Human Services

Class 2 Device Recall AU2700 and AU5400 Clinical Chemistry Analyzers

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  Class 2 Device Recall AU2700 and AU5400 Clinical Chemistry Analyzers see related information
Date Initiated by Firm April 26, 2013
Date Posting Updated May 29, 2013
Recall Status1 Terminated 3 on August 04, 2014
Recall Number Z-1430-2013
Recall Event ID 65118
510(K)Number K003721  K011720  
Product Classification Analyzer, chemistry (photometric, discrete), for clinical use - Product Code JJE
Product AU2700 Clinical Chemistry Analyzer
AU5400 Clinical Chemistry Analyzer

Perform automated analysis of serum, urine, and other body fluids, including whole blood.
Code Information All Serial Numbers

Model Numbers: AU2700, AU27000ISE, AU5421, AU5421ISE, AU5431.

Part Numbers:, E0750053, N3663400 , N3663700 , N3664000 , N3664200 , N3664400 , N3664600 , N3664800 , N3878500 , 1465600 , 64270G , E61DAU2700, N3663500 , N3663600 , N3663800 , N3663900 , N3664100 , N3664300 , N3664500 , N3664700 , N3664900 , N3878600 , O9102700, N3665000 , N3665100 , N3665200 , N3665300 , N3665400 , N3878300 , 64542 , A94504 , N1683100 , AU5431-U1 , N3665500 , N3665600 , N3665700 , N3665800 , N3665900 , N3878400 .
Recalling Firm/
Manufacturer
Beckman Coulter Inc.
250 S Kraemer Blvd
Brea CA 92821-6232
Manufacturer Reason
for Recall
Beckman Coulter is recalling AU2700/AU2700 Plus & AU5400 Clinical Chemistry Analyzers becuase it was determined that the tubing/joint connections associated with these MODs may leak concentrated detergent. Beckman Coulter has received complaints that the joint connecting the tubing appears to disintegrate over time, causing a leak.
FDA Determined
Cause 2
Component design/selection
Action Beckman Coulter sent an Urgent Product Correction letter on April 26, 2013 along with a response form. The letter notified customers of the product, problem, and actions to be taken by the customers. Contact the Call Center at 800-854-3633 for questions regarding this notice.
Quantity in Commerce 108 units
Distribution Worldwide Distribution-USA Nationwide and countries of: AU, CA, DE, ES, GB, IT, PT, and JP.
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.
510(K) Database 510(K)s with Product Code = JJE and Original Applicant = OLYMPUS AMERICA, INC.
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