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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 Recall
AU2700 and AU5400 Clinical Chemistry Analyzers
see related information
Date Posted May 29, 2013
Recall Status1 Open
Recall Number Z-1430-2013
Recall Event ID 65118
Premarket Notification
510(K) Numbers
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, California 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
DESIGN: 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 For details about termination of a recall see Code of Federal Regulations (CFR) Title 21 §7.55
2 Per FDA policy, recall cause determinations are subject to modification up to the point of termination of the recall.
510(K) Database 510(K)s with Product Code = JJE and Original Applicant = OLYMPUS AMERICA, INC.
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