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U.S. Department of Health and Human Services

Class 3 Device Recall

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 Class 3 Device Recallsee related information
Date Initiated by FirmNovember 05, 2004
Date PostedNovember 30, 2004
Recall Status1 Terminated 3 on March 16, 2005
Recall NumberZ-0267-05
Recall Event ID 30427
Product Classification Calculator/Data Processing Module, For Clinical Use - Product Code JQP
ProductDL2000 Data Manager Software, Version 6.4.108
Code Information Version 6.4.108
FEI Number 2050012
Recalling Firm/
Manufacturer		 Beckman Coulter Inc
200 S Kraemer Blvd
Brea CA 92822-6208
For Additional Information ContactKathleen 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
ActionLetters were sent to sites on November 5, 2004 to confirm previous telephone conversations with the consignees.
Quantity in Commerce3
DistributionProduct was under evaluation at three sites in FL, IL, and CA.
Total Product Life CycleTPLC 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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