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U.S. Department of Health and Human Services

Class 2 Device Recall Access/DxI Immunoassay System

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 Class 2 Recall
Access/DxI Immunoassay System
see related information
Date Posted December 13, 2010
Recall Status1 Terminated on July 11, 2012
Recall Number Z-0607-2011
Recall Event ID 56752
Premarket Notification
510(K) Numbers
K023049  K023764  K060256  K922823 
Product Classification Analyzer, Chemistry (Photometric, Discrete), For Clinical Use - Product Code JJE
Product Access Immunoassay Systems, Part Number: 81600 ; Access 2 Immunoassay Systems, Part Number: 81600N; Synchron LXi 725; UniCel DxI 800 Access Immunoassay Systems, Part Number: 973100; UniCel DxI 600 Access Immunoassay Systems, Part Number A30260; UniCel DxC 600i, Part Number: A25656; UniCel DxC 660i, Part Number: A64871; UniCel DxC 860i, Part Number: A64935; UniCel DxC 880i, Part Number: A59102; SYNCHRON Access Clinical Systems The Access/DxI Immunoassay System is an in vitro diagnostic device used for the quantitative, semi-quantitive or qualitative determination of various analyte concentration found in human body fluids. Function of the Peristaltic Pump: to aspirate unbound material from reaction vessels and to move waste from vacuum jar into waste bottle through associated tubing within the Access Immunoassay System.
Code Information All versions are affected.
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 Clair K. ODonovan, Ph.D.
714-961-4483
Manufacturer Reason
for Recall
This recall was initiated because Beckman Coulter has received reports of erroneous test results being reported as a result of assay reagent packs being transferred between systems. Erroneous results will be generated as a result of missing or incorrect assay reagents. In these cases both false positive and false negative results are possible, depending upon the assay configuration.
FDA Determined
Cause 2
OTHER/UNDETERMINED: Under Investigation by the firm
Action Beckman Coulter, Inc. sent two (2) Product Corrective Action (PCA) letters (Access letter and DxI letter) with attached Customer Response form the week of August 09, 2010 to the affected customers. The letters were dated August 13, 2010, and identified the product, the problem, and the action to be taken by the customers. The letter reminded customers that it is critical that they load reagent packs according to the procedure provided in their Access or Access 2 Operators Guide, Instructions for Use, or Help system. A copy of the procedure was included with the letter. Customers were reminded that all operators should be properly trained on these important procedures and understand the impact on reported results if these procedures are not followed. Customers were instructed to share this information with their laboratory staff, and retain this notification as part of their laboratory Quality System documentation. Customers who needed assistance or had any questions regarding this notification, were instructed to contact Technical Support at 1-800-854-3633, option 1 in the United States or Canada.
Quantity in Commerce 9571 units (instruments)
Distribution Nationwide Distribution & 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.
510(K)s with Product Code = JJE and Original Applicant = BIO-RAD LABORATORIES, INC.
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