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U.S. Department of Health and Human Services

Enforcement Report - Week of December 26, 2013

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Product Detail

Product Description Access Immunoassay Systems Reaction Vessels. 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.
Recall Number Z-0519-2014
Classification Class II
Code Info Part Number 81901, Lot Numbers: 13181168-13341170.
Product Distributed Qty 16,154 units
Reason For Recall Beckman Coulter is initiating a recall for the Access Immunoassay Systems Reaction Vessels, including the Acess/Access 2 Immunoassay Systems, SYNCRON LXi 725 Clinical System, and UniCel DxC 600i SYNCHRON Access Clinical System because Beckman Coulter has observed an intermittent increase in Access System "Wash Carousel Motion Errors" with specific lots of Access System Reaction Vessels (RVs). If your system is experiencing these errors, the errors will be documented in the event log and the system will be in the Not Ready mode.

Event Detail

Event Id 66521
Product Type Devices
Status Ongoing
Recalling Firm Beckman Coulter Inc.
City Brea
State CA
Country US
Voluntary / Mandated Voluntary: Firm Initiated
Recall Initiation Date 2013-10-02
Initial Firm Notification of Consignee or Public Letter
Distribution Pattern Worldwide Distribution - USA (nationwide) and Internationally to Canada, Japan, India, Hong Kong, Guatemala, China, Brazil, Brunei Darussalam, Costa Rica, El Salvador, JordanMalaysia, Mexico, Panama, Philippines, South Africa, Taiwan, Thailand, Trinidad and Tobago, United Arab Emirates, Venezuela, and Viet Nam.