| Class 3 Device Recall BD CD4 (SK3) FITC | |
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
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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
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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 |
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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.
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510(K) Database | 510(K)s with Product Code = GKZ
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