Company: Beckman Coulter Inc.
Date of Enforcement Report:12/25/2013
Class lI:
PRODUCT
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
REASON
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..
RECALLING FIRM/MANUFACTURER
Beckman Coulter Inc., Brea, CA on 10/2//2013. Voluntary: Firm Initiated recall is ongoing.
VOLUME OF PRODUCT IN COMMERCE
16,154 units
DISTRIBUTION
Nationwide and Internationallyp>
___________________________________
