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U.S. Department of Health and Human Services

Class 2 Device Recall BD BBL Taxo XV Factor Strips

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  Class 2 Device Recall BD BBL Taxo XV Factor Strips see related information
Date Initiated by Firm October 22, 2012
Date Posted December 13, 2012
Recall Status1 Terminated 3 on January 24, 2013
Recall Number Z-0523-2013
Recall Event ID 63723
Product Classification Antisera, fluorescent, all types, hemophilus spp. - Product Code GRO
Product BD BBL Taxo XV Factor Strips, Catalog number 231104, in shelf pack vials, fifty strips/vial labeled in part ***Becton, Dickinson and Company, 7 Loveton Circle, Sparks, MD 21152 USA 800-638-8663, www.bd.com/ds***
Code Information Lot number 2089253
Recalling Firm/
Manufacturer		 Becton Dickinson & Co.
BD Diagnostic Systems
7 Loveton Circle
Sparks MD 21152-0999
For Additional Information Contact Ms. Gail Claiborne
410-316-4054
Manufacturer Reason
for Recall		 In vitro diagnostic test kit was not manufactured according to specifications and may cause false negatives or misidentification of Hemophilus species present in patient specimens.
FDA Determined
Cause 2		 Employee error
Action BD Diagnostic Systems sent an Urgent Product Recall letter dated October 22, 2012, to all affected customers.. The letter identified the product, the problem, and the action to be taken by the customer. Customers were advised to discontinue distribution and discard affected inventory for credit. . Customers were requested to return a response form by fax to 410-316-4258. For questions customers were instructed to contact BD Customer Service Department at 1-800-638-8663. For assistance with replacements, customers were instructed to call 1-800-675-0908. For questions regarding this recall call 410-316-4258.
Quantity in Commerce 650 vials
Distribution Worldwide Distribution - USA (nationwide) to international customers in Belgium, India, Japan, South Korea, Thailand and Mexico
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.
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