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U.S. Department of Health and Human Services

Class 3 Device Recall

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  Class 3 Device Recall see related information
Date Initiated by Firm June 20, 2005
Date Posted August 16, 2005
Recall Status1 Terminated 3 on October 06, 2011
Recall Number Z-1372-05
Recall Event ID 32558
Product Classification Calculator/Data Processing Module, For Clinical Use - Product Code JQP
Product DL 2000 Data Manager
Code Information Not Applicable but refers to software version 6.4.109f
Recalling Firm/
Beckman Coulter Inc
200 S Kraemer Blvd
Brea CA 92822-6208
For Additional Information Contact Nancy Johnson
Manufacturer Reason
for Recall
Version v6.4.109f, any result designated as 'calculated chemistry' at DL2000 may upload to the LIS with an incorrect or blank sample ID.
FDA Determined
Cause 2
Action Recall letters were sent during the week of June 20, 2005. It explains the problem and indicates that an enclosed software correction must be installed to correct the problem.
Quantity in Commerce 287
Distribution Nationwide.
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.