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U.S. Department of Health and Human Services

Class 2 Device Recall AU Clinical Chemistry Analyzers

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  Class 2 Device Recall AU Clinical Chemistry Analyzers see related information
Date Initiated by Firm July 12, 2010
Date Posted February 07, 2012
Recall Status1 Terminated 3 on August 04, 2014
Recall Number Z-0977-2012
Recall Event ID 60919
510(K)Number K011720  
Product Classification Analyzer, chemistry (photometric, discrete), for clinical use - Product Code JJE
Product AU Clinical Chemistry Analyzers: Model Number:
AU5400 Clinical Chemistry Analyzer.

The AU Clinical Chemistry Analyzers are fully automated photometric analyzers intended for clinical laboratory use. Applications include colorimetric, turbidimetric, latex agglutination, and homogeneous enzyme immunoassay.
Code Information All analyzer serial numbers
Recalling Firm/
Manufacturer		 Beckman Coulter Inc.
250 S Kraemer Blvd
Brea CA 92821-6232
Manufacturer Reason
for Recall		 The recall was initiated because Beckman has confirmed that the AU Clinical Chemistry Analyzers may experience cuvette overflow.
FDA Determined
Cause 2		 Under Investigation by firm
Action Beckman Coulter sent an "UPDATE TO PCA -14563: URGENT PRODUCT CORRECTION" letter dated April 27, 2011 to all affected customers. The letter describes the product, problem, and actions to be taken by the customers. The letter is a communication which describes an alternative approach to detecting cuvette overflow. Additionally, a response form was enclosed for customers to complete and return to the firm. Contact the Customer Support Center at (800) 854-3633 or on the Beckman Coulter website at www.beckmancoulter.com/customersupport/support/default.asp for questions regarding this notification.
Quantity in Commerce 8225 units
Distribution Worldwide Distribution-including USA (nationwide).
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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