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U.S. Department of Health and Human Services

Class 2 Device Recall

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  Class 2 Device Recall see related information
Date Initiated by Firm March 29, 2004
Date Posted July 20, 2004
Recall Status1 Terminated 3 on September 07, 2004
Recall Number Z-0904-04
Recall Event ID 28851
510(K)Number K023764  
Product Classification Analyzer, Chemistry (Photometric, Discrete), For Clinical Use - Product Code JJE
Product UniCel Dxl 800 Access Immunoassay System, P/N 973100.
Code Information All software versions pior to version 1.4
Recalling Firm/
Manufacturer		 Beckman Coulter Inc
200 S Kraemer Blvd
Brea CA 92822-6208
For Additional Information Contact Kathleen M. Jaker
714-961-3666
Manufacturer Reason
for Recall		 Software coding error may cause a fatal error message.
FDA Determined
Cause 2		 Other
Action Each user will be contacted initially and then once more to ensure that the users have recieved the recall letter and have installed the new software included with the letter. Recall letters were sent March 29, 2003.
Quantity in Commerce 73
Distribution Nationwide and 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.
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