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U.S. Department of Health and Human Services

Class 2 Device Recall CellQuest Pro SW

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  Class 2 Device Recall CellQuest Pro SW see related information
Date Initiated by Firm September 07, 2007
Date Posted March 30, 2011
Recall Status1 Terminated 3 on March 31, 2011
Recall Number Z-1845-2011
Recall Event ID 57613
510(K)Number K946055  
Product Classification Differential Cell Counter - Product Code GKZ
Product CellQuest Pro SW, version 4.0.2. and later;
Becton Dickinson, San Jose, CA 95131

CellQuest Pro software allows you to acquire and analyze data from your flow cytometer on a Macintosh computer.
Code Information Catalog numbers: 343926, 339455, 343928, 347527, and 347526.
Recalling Firm/
Manufacturer		 BD Biosciences, Systems & Reagents
2350 Qume Dr
San Jose CA 95131-1812
For Additional Information Contact Eric Clausen
408-954-6307
Manufacturer Reason
for Recall		 Results and gates could be mismatched if you utilize the undo function to undo a gate that was deleted.
FDA Determined
Cause 2		 Software design
Action Important Product Information letters, dated September 2007, were sent the week of 9/14/2001 via Federal Express to all affected customers. The letters identified the affected product along with the reason for recall. The letter states that "as long as customers do not use the Undo function to undo a gate deletion, the software can be used with full functionality." The letter also states that BD will change the issue in the next software version. If customers believe that they may have analyzed sample files by utilizing the Undo function, then it is recommended that the sample files be re-analyzed. If customers need more information they should contact the Customer Support Center at 877-232-8995.
Quantity in Commerce 4552
Distribution Worldwide Distribution
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 = GKZ and Original Applicant = BECTON DICKINSON IMMUNOCYTOMETRY SYSTEMS
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