||May 29, 2013
||Terminated on August 04, 2014
|Recall Event ID
Analyzer, Chemistry (Photometric, Discrete), For Clinical Use - Product Code JJE
||AU2700 Clinical Chemistry Analyzer
AU5400 Clinical Chemistry Analyzer
Perform automated analysis of serum, urine, and other body fluids, including whole blood.
||All Serial Numbers
Model Numbers: AU2700, AU27000ISE, AU5421, AU5421ISE, AU5431.
|Beckman Coulter Inc.
250 S Kraemer Blvd
Brea, California 92821-6232
|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.
|DESIGN: Component Design/Selection
||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
||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)s with Product Code = JJE and Original Applicant = OLYMPUS AMERICA, INC.