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U.S. Department of Health and Human Services

Class 3 Device Recall BD CD4 (SK3) FITC

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  Class 3 Device Recall BD CD4 (SK3) FITC see related information
Date Initiated by Firm August 27, 2015
Date Posted September 24, 2015
Recall Status1 Terminated 3 on August 09, 2016
Recall Number Z-2817-2015
Recall Event ID 72071
510(K)Number K900802  
Product Classification Counter, differential cell - Product Code GKZ
Product CD4 (SK3), FITC;
Contains CD4 FITC with gelatin and 0.1% sodium Azide.
Catalog number 340133

in vitro diagnostic used in Hematology: The SK3 monoclonal antibody reacts with human CD4, a 59-kDa cell surface receptor expressed by a majority of thymocytes, a subpopulation of mature T helper cells, and at low levels on monocytes. CD4 is a receptor for the human immunodeficiency virus (HIV).
Code Information Catalog Number 340133; lot # 5112711, Expiration date: 30 Nov 2016.
Recalling Firm/
Manufacturer		 Becton, Dickinson and Company, BD Biosciences
2350 Qume Dr
San Jose CA 95131-1812
For Additional Information Contact Eric Claussen
408-954-6307
Manufacturer Reason
for Recall		 CD4 FITC label contains an error in the Spanish small text - it states CD8 FITC.
FDA Determined
Cause 2		 Under Investigation by firm
Action Urgent Product Recall notification letters were sent to each customer on August 27, 2015 by certified mail.
Quantity in Commerce 128 units
Distribution Worldwide Distribution. US nationwide (TX, CA, NC, OH, SD, PA, CT, UT, MD, TX, GA), Argentina, Taiwan, Australia, Japan, China, New Zealand, Chile and Colombia.
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 BECTON DICKINSON VACUTAINER SYSTEMS PREANALYTIC
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