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.
FDA Recall Z-0612-2013 · Posted 2012-12-22
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Recalling FirmBeckman Coulter Inc.
Recall StatusTerminated
Product CodeJJE
Date Initiated2012-11-01
Date Terminated2013-12-23
Product Quantity6,858 units
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.
Firm 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.
Root Cause
Device Design
Distribution Pattern
Worldwide Distribution-USA (nationwide) and the country of Canada.
Related FDA 510(k) Records
Devices referenced by this recall via K-numbers.
Official Source
View FDA Recall →Source: FDA Enforcement Report / Recall database. Always confirm against the official FDA record.
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