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U.S. Department of Health and Human Services

Class 2 Device Recall UniCel DxI 600 Access Immunoassay System Analyzer

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  Class 2 Device Recall UniCel DxI 600 Access Immunoassay System Analyzer see related information
Date Initiated by Firm November 26, 2013
Date Posted February 16, 2014
Recall Status1 Terminated 3 on July 27, 2014
Recall Number Z-0985-2014
Recall Event ID 66958
510(K)Number K023764  
Product Classification Analyzer, chemistry (photometric, discrete), for clinical use - Product Code JJE
Product UniCel DxI 600 Access Immunoassay System Analyzer.

The Access Immunoassay System is an in vitro diagnostic device used for the quantitative, semi-quantitative or qualitative determination of various analyte concentrations found in human body fluids.
Code Information Part Number A30260. Serial Numbers 900781.
Recalling Firm/
Manufacturer		 Beckman Coulter Inc.
250 S Kraemer Blvd
Brea CA 92821-6232
Manufacturer Reason
for Recall		 The Access 2 Immunoassay System Analyzer and the UniCel DxI 600 Access may have been manufactured with non-conforming bushings. Non-conforming bushings have a remote probability of generating incorrect results.
FDA Determined
Cause 2		 Nonconforming Material/Component
Action Beckman Coulter initiated this recall by sending recall notifications to customers. An Urgent Product Correction letter sent to affected customers. The recall letter dated November 22, 2013 informed customer of the recall, products with description and codes, issue, impact, action, resolution, and contact information.
Quantity in Commerce 1 unit
Distribution Worldwide Distribution: US Distribution in South Dakota and the countries of Germany, Lebanon, and China.
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 = BECKMAN COULTER, INC.
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