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U.S. Department of Health and Human Services

Class 2 Device Recall BD BACTEC(tm) MGIT (tm) 960 System

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  Class 2 Device Recall BD BACTEC(tm) MGIT (tm) 960 System see related information
Date Initiated by Firm March 28, 2011
Date Posted July 28, 2011
Recall Status1 Terminated 3 on July 29, 2011
Recall Number Z-2890-2011
Recall Event ID 59036
510(K)Number K974883  
Product Classification System, blood culturing - Product Code MDB
Product BD BACTEC(tm) MGI (tm) System Software, Catalog 445922, Lot V5.02A.

Product Usage: The BACTEC(tm) MGIT (tm) System Software is used in the MGIT 960 and MGIT 320 instruments for the rapid detection of mycobacteria from clinical specimens. In addition, an Antimicrobial/Drug Susceptibility Testing (AST or DST) system is used as 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 a tube for each drug, as well as a barcoded tube carrier that holds the set. The carrier 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. 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 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 Lot number V5.02A, Catalog #445922
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
Software contained three additional set configurations which caused the system to reinitialized the AST set carrier defaults.
FDA Determined
Cause 2
Software design (manufacturing process)
Action BD Diagnostic Systems verbally notified all affect customers via the telephone on March 28, 2011. The notification identified the product, the problem, and the action to be taken by the customer. An "URGENT PRODUCT RECALL" follow-up letter was mailed to all customers on April 8, 2011 via UPS. Customers were instructed to complete and fax the attached reply form to acknowledge their receipt of the notification to Regulatory Compliance, 410-316-4256. The letter instructs customers to refer to the modified release notes and IMPORTANT NOTICES outlined in the attached notification letter. If further assistance is needed regarding replacements and all other inquires, please contact BD Technical Services and Support at 1-800-638-8663.
Quantity in Commerce 421 disks
Distribution Nationwide Distribution (USA) including states of: AK, AL, AR, CA, CO, CT, DE, FL, GA, HI, IA, IL, IN, KS, KY, LA, MA, MD, MN, MO, MS, MT, NC, NE, NH, NJ, NM, NV, NY, OH, OK, OR, PA, RI, SC, SD, TN, TX, UT, VA, WA, and WI.
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 = MDB and Original Applicant = BD BECTON DICKINSON VACUTAINER SYSTEMS PREANALYTIC