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U.S. Department of Health and Human Services

Class 2 Device Recall BBL Crystal Enteric/Nonfermenter ID Kit

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  Class 2 Device Recall BBL Crystal Enteric/Nonfermenter ID Kit see related information
Date Initiated by Firm December 13, 2012
Date Posted January 20, 2013
Recall Status1 Terminated 3 on June 03, 2013
Recall Number Z-0699-2013
Recall Event ID 63958
510(K)Number K926018  
Product Classification Kit, identification, enterobacteriaceae - Product Code JSS
Product Becton, Dickinson and Company, BBL Crystal Enteric/Nonfermenter ID Kit, Catalog # 24500, cartons of 20 kits, In-vitro diagnostic reagents for microbiological testing.
The BBL Crystal Enteric/Nonfermentor (E/NF) identification (ID) System is for the identification of aerobic gram-negative bacteria that belong to the family Enterobacteriaceae as well as some of the more frequently isolated glucose fermenting and nonfermenting gram-negative bacilli.
Code Information Lot Number/ Exp Date 2086315 February 20, 2013 2101435 February 20, 2013 2104316 February 27, 2013 2129460 February 27, 2013 2129487 March 13, 2013 2163211 February 27, 2013 2163213 March 20, 2013 2163215 March 27, 2013  
Recalling Firm/
Manufacturer		 Becton Dickinson & Co.
BD Diagnostic Systems
7 Loveton Circle
Sparks MD 21152-0999
For Additional Information Contact Gail Claiborne
410-316-4054
Manufacturer Reason
for Recall		 In-vitro diagnostic reagents for microbiological testing may be reversed in well positions in the test kit and when utilized may lead to bacteria misidentification.
FDA Determined
Cause 2		 Mixed-up of materials/components
Action Becton Dickinson initiated the recall by letter to direct accounts on 12/13/2012. Ex-US BD sites were notified via email, distributors were notified by fax and customer letters were delivered by UPS ground. The notification advised that the recalled kit contained citrate (CIT} and malonic acid (MLO} reagents in the reversed prong/well positions. Customers were advised to discontinue use of identified lot numbers and discard any remaining packages for replacements, and also to return the enclosed reply form. The recalling firm requested distributors to submit their customer list for direct BD notification to all end users. Contact the BD Customer Service Department at 1-800-638-8663 if further assistance is required.
Quantity in Commerce 67,820 units
Distribution Worldwide Distribution-USA including the states of MA, TN, KY, IN, GA, NC, TX, NY, FL, AZ, WA, NJ, MI, and CA, and the countries of Uruguay, Taiwan, Singapore, Australia, South Korea, Mexico, Hong Kong, Guatemala, Colombia, Chile, Canada, India, Japan, Brazil, China and Belgium.
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 = JSS and Original Applicant = BECTON DICKINSON MICROBIOLOGY SYSTEMS
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