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U.S. Department of Health and Human Services

Class 2 Device Recall MultiSET

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  Class 2 Device Recall MultiSET see related information
Date Initiated by Firm September 06, 2007
Date Posted March 04, 2008
Recall Status1 Terminated 3 on April 15, 2008
Recall Number Z-0570-2008
Recall Event ID 45447
510(K)Number K963963  
Product Classification Flow Cytometry Software - Product Code GKZ
Product BD Biosciences MultiSET Flow Cytometry Software Versions 2.1, 2.1.1, and 2.2 with OS X operating systems, BD Biosciences, San Jose, CA 95131.
Code Information Software Versions 2.1, 2.1.1, and 2.2 with OS X operating systems.  
Recalling Firm/
Manufacturer		 BD Biosciences
2350 Qume Dr
San Jose CA 95131-1807
For Additional Information Contact
408-954-6307
Manufacturer Reason
for Recall		 Inaccurate results: Software error results in inaccurate display result statistics. If the user adjusts the lymph gate or attractors in the Lab Report view without using the Manual Gate function (as described in the system manual), the statistic results will not be updated to match the adjusted gate.
FDA Determined
Cause 2		 Software design
Action Becton Dickinson sent an Important Product Information letter by mail on 09/14/2007 informing customers of the need to follow the instructions for adjusting the lymph gate or attractors. The next software revision will alleviate this limitation.
Quantity in Commerce 1136 units
Distribution Worldwide Distribution - USA, Belgium, Brazil, Peru, Singapore, Canada, Jamaica, Chile, Ecuador, Hong Kong-China, Thailand, Mexico, Venezuela, Barbados, Philippines, Puerto Rico, Guatemala, Japan, Uruguay, Argentina, China, Trinidad and Tobago, Honduras, Australia, New Zealand, and India.
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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