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U.S. Department of Health and Human Services

Class 2 Device Recall BD CD8 (SK1) phycoerythrin (PE)

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  Class 2 Device Recall BD CD8 (SK1) phycoerythrin (PE) see related information
Date Initiated by Firm December 19, 2014
Date Posted January 20, 2015
Recall Status1 Terminated 3 on February 23, 2016
Recall Number Z-1000-2015
Recall Event ID 70107
510(K)Number K904390  
Product Classification Counter, cell, automated (particle counter) - Product Code GKL
Product CD8 (Leu-2a) PE (In vitro diagnostic), Catalog number 340046.
Hematology: Single color direct immunofluorescence reagent for enumerating percentages of mature human suppressor/cytotoxic (CD8+) lymphocytes in erythrocyte-lysed whole blood or peripheral blood mononuclear cell suspensions.
Code Information Lot number 4220622, Expiry 2016-04-30.
Recalling Firm/
Manufacturer		 BD Biosciences, Systems & Reagents
2350 Qume Dr
San Jose CA 95131-1812
For Additional Information Contact Diane Brooks-Smith
408-954-6307
Manufacturer Reason
for Recall		 One lot of CD8 PE is contaminated with CD4 FITC and may cause an unexpected staining pattern and incorrect patient data.
FDA Determined
Cause 2		 Process control
Action Recall notification letters were sent to all consignees on December 19, 2014 by certified mail.
Quantity in Commerce 165 units
Distribution Worldwide distribution. US Nationwide including Puerto Rico, China, Brazil, Japan, Guatemala, India, New Zealand, Australia, Canada, Thailand, Chile and Malaysia.
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 = GKL and Original Applicant = BD BECTON DICKINSON VACUTAINER SYSTEMS PREANALYTIC
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