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U.S. Department of Health and Human Services

Class 2 Device Recall Access Immunoassay Systems

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 Class 2 Recall
Access Immunoassay Systems
see related information
Date Posted February 25, 2010
Recall Status1 Terminated on May 07, 2012
Recall Number Z-0856-2010
Recall Event ID 53679
Premarket Notification
510(K) Numbers
K023764  K060256 
Product Classification Analyzer, Chemistry (Photometric, Discrete), For Clinical Use - Product Code JJE
Product UniCel DxI 800 and 600 Access Immunoassay Systems, UniCel DxC 880i, 860i, 660i, and 680i SYNCHRON Access Clinical Systems with Dxl System Software versions 4.2 or 4.2.1. In vitro diagnostic device used for the quantitative, semi-quantitive or qualitative determination of various analyte concentrations found in human body fluids.
Code Information DxI software versions: 4.2 and 4.2.1. For labeling see UniCel DxI Operator's Guide. Part Number: 387262G
Recalling Firm/
Manufacturer
Beckman Coulter Inc.
200 S Kraemer Blvd
Brea, California 92821-6208
Consumer Instructions Contact the recalling firm for information
For Additional Information Contact Nora Zerounian
714-961-3634
Manufacturer Reason
for Recall
This recall was initiated because of software issue was identified in System Software 4.2 and 4.2.1, which may result in the incorrect handling of a wash arm dispense plate motion failure. Instead of generating a red warning event and stopping sample processing, the system will post a yellow caution event and continue to operate with the dispense plate in an elevated position until the instrument
FDA Determined
Cause 2
DESIGN: Software Design
Action Beckman Coulter issued an "Urgent: Product Corrective Action" letter dated October 28, 2009. Customers were notified of the affected product and how the issue will be resolved. For further information, contact Beckman Coulter Inc. Technical Support at 1-800-854-3633.
Quantity in Commerce 377 Instruments
Distribution Worldwide Distribution -- United States and Canada.
Total Product Life Cycle TPLC Device Report

 
1 For details about termination of a recall see Code of Federal Regulations (CFR) Title 21 §7.55
2 Per FDA policy, recall cause determinations are subject to modification up to the point of termination of the recall.
510(K) Database 510(K)s with Product Code = JJE and Original Applicant = BECKMAN COULTER, INC.
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