| Class 2 Device Recall Access Immunoassay System |  |
Date Initiated by Firm | November 01, 2012 |
Date Posted | December 22, 2012 |
Recall Status1 |
Terminated 3 on December 23, 2013 |
Recall Number | Z-0612-2013 |
Recall Event ID |
63632 |
510(K)Number | K023049 K060256 K922823 |
Product Classification |
Analyzer, chemistry (photometric, discrete), for clinical use - Product Code JJE
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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
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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 |
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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.
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510(K) Database | 510(K)s with Product Code = JJE 510(K)s with Product Code = JJE
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