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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 05, 2004
Date Posted November 30, 2004
Recall Status1 Terminated 3 on March 16, 2005
Recall Number Z-0267-05
Recall Event ID 30427
Product Classification Calculator/Data Processing Module, For Clinical Use - Product Code JQP
Product DL2000 Data Manager Software, Version 6.4.108
Code Information Version 6.4.108
Recalling Firm/
Manufacturer		 Beckman Coulter Inc
200 S Kraemer Blvd
Brea CA 92822-6208
For Additional Information Contact Kathleen Jaker
714-961-3666
Manufacturer Reason
for Recall		 Possibility of reporting an incorrect result occurs due to a software anomally.
FDA Determined
Cause 2		 Other
Action Letters were sent to sites on November 5, 2004 to confirm previous telephone conversations with the consignees.
Quantity in Commerce 3
Distribution Product was under evaluation at three sites in FL, IL, and CA.
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.
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