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U.S. Department of Health and Human Services

Class 2 Device Recall BD Vacutainer

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  Class 2 Device Recall BD Vacutainer see related information
Date Initiated by Firm August 20, 2004
Date Posted October 28, 2004
Recall Status1 Terminated 3
Recall Number Z-1603-05
Recall Event ID 30104
510(K)Number K771370  K931368  K940905  K991702  K002456  
Product Classification Microtainer serum tubes - Product Code JKA
Product BD Vacutainer Microtainer Serum tubes (with or without gel).
Code Information There is no linkage to any particular lot of BD product.
Recalling Firm/
Manufacturer		 Becton Dickinson & Company
1 Becton Dr
Franklin Lakes NJ 07417-1815
For Additional Information Contact Kevin Nolan
201-847-5651
Manufacturer Reason
for Recall		 "Please be aware that this is not a new recall. This recall was initially classified in 2005 (Z-0052-05). The firm has taken action; but, due to administrative issues additional products are now being classified by the agency". There is an apparent bias in the determination of Total T3, Total T4, HBsAg, Folate BA, VB 12, BR, FSH and Cortisol hormones used to determine thyroid disease states, and
FDA Determined
Cause 2		 Other
Action The firm sent out a Technical Bulletin to all consignees of the specific instrument companies involved. Mailing initial were done 9/17/2004 and a revised mailing was sent 9/23/2004. Global communication will commense 10/5/2004.
Quantity in Commerce There is no linkage to any particular lot of BD product
Distribution Worldwide distribution.
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 = JKA and Original Applicant = BD BECTON DICKINSON VACUTAINER SYSTEMS PREANALYTIC
510(K)s with Product Code = JKA and Original Applicant = BECTON DICKINSON VACUTAINER SYSTEMS
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