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U.S. Department of Health and Human Services

Class 2 Device Recall BD FACS Sample Prep Assistant II

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  Class 2 Device Recall BD FACS Sample Prep Assistant II see related information
Date Initiated by Firm October 02, 2007
Date Posted April 10, 2008
Recall Status1 Terminated 3 on December 13, 2010
Recall Number Z-0526-2008
Recall Event ID 45880
510(K)Number K050191  
Product Classification Differential Cell Counter - Product Code GKI
Product BD FACS Sample Prep Assistant II, Part Number: 337170;
Product is manufactured and distributed by BD Biosciences, San Jose, CA 95131
Code Information Serial Numbers: T0246 to T0290 (except for T0274,T0275,T0277 and T0279)  
Recalling Firm/
Manufacturer		 BD Biosciences
2350 Qume Dr
San Jose CA 95131-1807
For Additional Information Contact Kim Ky
408-954-2610
Manufacturer Reason
for Recall		 Mixing Performance: SPA II devices manufactured with the affected product motor control board may exhibit suboptimal mixing performance.
FDA Determined
Cause 2		 Software change control
Action On 10/1/07, all consignees were notified via Important Product Information letter and also an on-site visit by the firm's sales representative. The letter informed users of the affected product and provided instructions on the recall. For additional concerns or questions contact BD Customer Support Center at 1-877-232-8995.
Distribution Worldwide Distribution --- USA including states of: NJ, IL, TX, PA, NY, MN, and AZ, and countries of Australia, Belgium, Hong Kong, Trinidad and Tobago. Australia, Belgium, Hong Kong, Trinidad and Tobago.
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 = GKI and Original Applicant = BECTON DICKINSON & CO.
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