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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 November 03, 2003
Date Posted July 28, 2004
Recall Status1 Terminated 3 on August 30, 2004
Recall Number Z-1096-04
Recall Event ID 28967
Product DataLink 2000 Data Manager
Code Information Version 6.3
Recalling Firm/
Manufacturer		 Beckman Coulter Inc
200 S Kraemer Blvd
Brea CA 92822-6208
Manufacturer Reason
for Recall		 Software anomaly allows results to be archived prior to validation or to be uploaded to the lab information system.
FDA Determined
Cause 2		 Other
Quantity in Commerce 361
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.
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