Company:Beckman Coulter Inc.
Date of Enforcement Report: 8/7/2013
Class ll:
PRODUCT
AU5800 Clinical Chemistry Analyzer with Automation Ready Connection (All Software Versions), Model Numbers AU5811, AU5821, AU5831 and AU5841. This system is for in vitro diagnostic use only. Recall Number Z-1834-2013
REASON
The recall was initiated because Beckman Coulter has identified a software error on AU5800 analyzers with the Automation Ready (AR) Sampler Kit. This software error results in the failure of the concentrated wash solution pump to stop, creating an overflow or leak on each analyzer unit.
RECALLING FIRM/MANUFACTURER
Beckman Coulter Inc., Brea, CA on 6/3/2013 Voluntary: Firm Initiated recall is ongoing.
VOLUME OF PRODUCT IN COMMERCE
76 units
DISTRIBUTION
Nationwide and Internationally
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