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U.S. Department of Health and Human Services

Class 2 Device Recall BD FACSDiva

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  Class 2 Device Recall BD FACSDiva see related information
Date Initiated by Firm December 21, 2007
Date Posted August 08, 2008
Recall Status1 Terminated 3 on September 24, 2008
Recall Number Z-1530-2008
Recall Event ID 46372
510(K)Number K040725  K062087  
Product Classification Differential cell counter - IVD - Product Code GKZ
Product BD FACSDiva Software v6.0 and 6.1 with the HP XW4400 Computer System
Model/Catalog number 642685

Software is used to simplify acquisition of flow cytometry data.
Code Information Material numbers 338960, 338962, and 339473
Recalling Firm/
BD Biosciences
2350 Qume Dr
San Jose CA 95131-1807
For Additional Information Contact
Manufacturer Reason
for Recall
Values might not update in statistics views after certain functions are performed in a worksheet.
FDA Determined
Cause 2
Software design
Action The firm issued an Important Product Information notification letter on 12/21/2007. The letter instructs users to reload data by closing and reopening an experiment before reporting results in order to determine if their statistics have been impacted. They are asked to fill out and return a form pertaining to this problem. BD Biosciences will release a version of BD FACSDiva software to correct this problem. The letter also stated that BD Biosciences rep will contact the users when the new software is available. User are asked to contact BD Customer Support Center at 1-877-232-8995 if they have any additional questions.
Quantity in Commerce 74 units
Distribution Nationwide 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 = BD Biosciences
510(K)s with Product Code = GKZ and Original Applicant = BECTON DICKINSON IMMUNOCYTOMETRY SYSTEMS