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U.S. Department of Health and Human Services

Class 2 Device Recall BD Biosciences FACSDiva Software Versions 4.0.1 to 5.0.2

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  Class 2 Device Recall BD Biosciences FACSDiva Software Versions 4.0.1 to 5.0.2 see related information
Date Initiated by Firm April 05, 2007
Date Posted August 16, 2008
Recall Status1 Terminated 3 on September 30, 2009
Recall Number Z-1525-2008
Recall Event ID 38337
510(K)Number K062087  
Product Classification Differential Cell Counter - Product Code GKZ
Product FACSDiva Software Versions 4.0.1 to 5.0.2, Flow Cytometry Acquisition & Analysis software. Catalog number 641609

Flexible data acquistion and analysis package specifically designed for digital-based flow cytometers.
Code Information Software versions 4.0.1 to 5.0.2.
Recalling Firm/
Manufacturer		 BD Biosciences
2350 Qume Dr
San Jose CA 95131-1807
For Additional Information Contact
408-954-6307
Manufacturer Reason
for Recall		 When data file containing one or no fluoresence parameters is exported, the software will automatically apply compensation to this file and all subsequently exported files.
FDA Determined
Cause 2		 Software design
Action The firm has issued a customer Important Product Information letter via mail on 04/20/2007 to inform them of the software issues. The letter states that to avoid this problem, make sure each tube or well has at least two fluorescence parameters before exporting FCS 3.0 data files. Manually exporting tubes or wells one at a time or restarting the software after the export of an FCS data file containing one or no fluorescence parameters will prevent the problem from occurring. Customers are requested to fill out and return the response form and to contact BD Customer Support Center if there are any additional questions. A software fix is being developed in version 6.0 and a free maintenance release with no product enhancments (version 5.0.3).
Quantity in Commerce 1074 units
Distribution Worldwide Distribution --- USA including states of NY, NM, MI, GA, MD, MA, AL, CA, VA, NC, OH, TX, CO, NJ, PA, MI, CT, IA, MO, NV, KY, IL, TN, FL, MN, FL, UT, WA, OK, CT, WI, SD, AZ, and IN, and countries of Buenos Aires, BE, Brazil, Canada, Chile, China, Hong Kong, Japan, Singapore, Taiwan, Venezuela, Mexico, Trinidad and Tobago, and Columbia.
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
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