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U.S. Department of Health and Human Services

Class 2 Device Recall Access Immunoassay Systems Reaction Vessels

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 Class 2 Recall
Access Immunoassay Systems Reaction Vessels
see related information
Date Posted December 16, 2013
Recall Status1 Terminated on October 23, 2014
Recall Number Z-0519-2014
Recall Event ID 66521
Premarket Notification
510(K) Numbers
K023049  K060256 
Product Classification Analyzer, Chemistry (Photometric, Discrete), For Clinical Use - Product Code JJE
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.
Code Information Part Number 81901, Lot Numbers: 13181168-13341170.
Recalling Firm/
Manufacturer
Beckman Coulter Inc.
250 S Kraemer Blvd
Brea, California 92821-6232
Manufacturer 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). I
FDA Determined
Cause 2
OTHER/UNDETERMINED: Pending
Action Beckman Coulter sent an Urgent Product Correction (PCA) letter dated October 1, 2013, along with a customer response form to all affected customers on October 2, 2013. The customer letter informed customers of the recall with the issue, impact, action (If your Access Immunoassay System experiences Wash Carousel Motion Errors that cannot be corrected with normal troubleshooting measures as outlined in the Access 2 Reference Manual section 6.3, contact Beckman Coulter Customer Technical Support. If you do not have Access System RVs with the lot numbers listed above, or if your Access Immunoassay System is not experiencing Wash Carousel Motion Errors, no additional action is required.), resolution, and contact information, website: http://www.beckmancoulter.com. Customers in the United States and Canada with questions were instructed to call 1-800-854-3633, outside the United States and Canada, customers were instructed to contact their local Beckman Coulter representataive. For questions regarding this recall call 714-961-4941.
Quantity in Commerce 16,154 units
Distribution 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.
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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