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U.S. Department of Health and Human Services

Class 2 Device Recall Access Immunoassay System

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  Class 2 Device Recall Access Immunoassay System see related information
Date Initiated by Firm November 01, 2012
Date Posting Updated December 22, 2012
Recall Status1 Terminated 3 on December 23, 2013
Recall Number Z-0612-2013
Recall Event ID 63632
510(K)Number K922823  K023049  K060256  
Product Classification Analyzer, chemistry (photometric, discrete), for clinical use - Product Code JJE
Product Access Immunoassay System,
Access 2 Immunoassay System,
Synchron LXi 725 Clinical
System, UniCel DxC 600i
Synchron Access Clinical System

Part Numbers: Access  81600;
Access 2  81600N, 386220, A69186, A25656, A12900;
Access 2 (LXi)  A15642;
Access 2 Section, DxC 600i  A25640.

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. The Synchron LXi and the UniCel DxC 600i are Access systems integrated with a chemistry analyzer.
Code Information Part Numbers: Access  81600;, Access 2  81600N, 386220, A69186, A25656, A12900;, Access 2 (LXi)  A15642;, Access 2 Section, DxC 600i  A25640
Recalling Firm/
Manufacturer
Beckman Coulter Inc.
250 S Kraemer Blvd
Brea CA 92821-6232
Manufacturer Reason
for Recall
It has been determined that, in some cases, pulley drive components have broken parts or have become loose, mispositioned, or disconnected from their drive shafts. When these defects occur, the pulley may not turn at all, or may turn at an incorrect speed, resulting in inadequate washing or mixing of the contents of the reaction vessel.
FDA Determined
Cause 2
Device Design
Action Beckman Coulter sent an "URGENT PRODUCT CORRECTION" letter dated November 1, 2012 to all affected customers. The letter identified the product, problem, and actions to be taken by the customers. Customers were asked to complete and return an enclosed Response Form. Contact Technical Support for questions regarding this notice.
Quantity in Commerce 6,858 units
Distribution Worldwide Distribution-USA (nationwide) and the country of Canada.
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.
510(K)s with Product Code = JJE and Original Applicant = BIO-RAD LABORATORIES, INC.
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