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U.S. Department of Health and Human Services

Class 2 Device Recall BACTEC(tm) MGIT(tm) AST Label Spares

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  Class 2 Device Recall BACTEC(tm) MGIT(tm) AST Label Spares see related information
Date Initiated by Firm August 31, 2010
Date Posted May 05, 2011
Recall Status1 Terminated 3 on July 08, 2011
Recall Number Z-2142-2011
Recall Event ID 58480
Product Classification Susceptibility test powers, antimycobacterial - Product Code MJA
Product BACTEC(tm) MGIT(tm) AST Label Spares, Catalog 445959. Kit contains Contains 5 each of the 5-Tube and 2-Tube Barcoded Labels. ***Becton, Dickinson and Company
7 Loveton Circle Sparks, Maryland 21152***
The BACTEC MGIT AST system is a rapid qualitative procedure for susceptibility testing of Mycobacterium tuberculosis, from culture, to streptomycin, isoniazid, rifampin, ethambutol, and pyrazinamide. The routine AST set consists of a Growth Control tube and one tube for each drug, as well as a barcoded tube carrier that holds the set. The barcode provides set size and identification. A tube rack capable of holding up to 55 AST tubes in various set combinations is available for tube setup and transport. (Large or small AST carrier sets can be placed in the rack also.) The MGIT AST system is based on growth of the Mycobacterium tuberculosis strain under test as measured by the instrument. AST sets are entered into the BACTEC MGIT 960 instrument and are tested automatically. Analysis of fluorescence in a drug containing tube is compared to the fluorescence of the Growth Control tube to determine susceptibility results.
Code Information not coded
Recalling Firm/
Becton Dickinson & Co.
BD Diagnostic Systems
7 Loveton Circle
Sparks MD 21152-0999
For Additional Information Contact Kimberly Cartier
Manufacturer Reason
for Recall
In vitro diagnostic device components are mislabeled.
FDA Determined
Cause 2
Action BD Diagnostic Systems sent an Urgent Product Recall letter on August 31, 2010, to all affected customers. The letter identified the product, the problem, and the action to be taken by the customer. The letter advised customers to discard any carriers or labels that contain the incorrect barcode for replacement. Accounts were requested to complete an attached reply form to acknowledge their receipt of the notification and fax it to 410-316-4258. For questions regarding this recall call BD Customer Service at 1-800-675-0908.
Quantity in Commerce 4123 total labels
Distribution Worldwide Distribution - USA including CA, MA, MD, VA and the countries of Argentina, Colombia, Belgium, China, India, Hong Kong, Peru, Singapore, Thailand, and Trinidad.
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.