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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 Device Recall Access Immunoassay Systems see related information
Date Initiated by Firm September 11, 2008
Date Posted April 06, 2012
Recall Status1 Terminated 3 on June 26, 2012
Recall Number Z-1375-2012
Recall Event ID 61118
510(K)Number K060256  
Product Classification Analyzer, chemistry (photometric, discrete), for clinical use - Product Code JJE
Product Access Immunoassay Systems Assay Protocol File (APF) Software versions for UniCel DxC 600i Systems.

Part Number: A54378, UniCel DxC 600i APF,
Part Number: A54379, UniCel DxC 600i AAF.

The Access Immunoassay System is an in vitro diagnostic device used for the quantitative, semi-quantitative or qualitative determination of various analyte concentration found in human body fluids.
Code Information Part Number: A54378, UniCel DxC 600i APF,  Lot Numbers: 722631, 823677. Part Number: A54379, UniCel DxC 600i AAF, Lot Numbers: 722630, 823675.
Recalling Firm/
Beckman Coulter Inc.
250 S Kraemer Blvd
Brea CA 92821-6232
For Additional Information Contact B. Melina Cimler, Ph.D
Manufacturer Reason
for Recall
The recall was initiated because Beckman confirmed a customer report that a timing conflict can occur while aspirating samples for the Access Total BhCG assay.
FDA Determined
Cause 2
Software design
Action Beckman Coulter sent a "PRODUCT CORRECTIVE ACTION" letter dated September 24, 2008 to all affected customers. The letter identified the product, problem, and actions to be taken by the customers. Customers were instructed to share this information with their laboratory staff and retain the notification as part of their laboratory Quality System documentation. Customers were instructed to complete and return the enclosed response form. Customers with questions regarding this notification were instructed to contact Technical Support at (800) 854-3633 or their local Beckman Coulter representative.
Quantity in Commerce 2948 units total (2762 units in the US)
Distribution Worldwide Distribution-USA (nationwide) and the country of Canada.
Total Product Life Cycle TPLC Device Report

1 A record in this database is created when a firm initiates a correction or removal action. The record is updated if the FDA identifies a violation and classifies the action as a recall, and it is updated for a final time when the recall is terminated. Learn more about medical device recalls.
2 Per FDA policy, recall cause determinations are subject to modification up to the point of termination of the recall.
3 For details about termination of a recall see Code of Federal Regulations (CFR) Title 21 §7.55.
510(K) Database 510(K)s with Product Code = JJE and Original Applicant = BECKMAN COULTER, INC.