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
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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 |
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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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510(K) Database | 510(K)s with Product Code = GKZ
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