Company: Becton Dickinson & Co..
Date of Enforcement Report 8/31/11
Class ll:
PRODUCT
BD BACTEC(tm) MGIT ™ System Software, Catalog 445922. Product Usage: The BACTEC(tm) MGIT ™ 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. Recall # Z-2890-2011
REASON
Software contained three additional set configurations which caused the system to reinitialized the AST set carrier defaults.
RECALLING FIRM/MANUFACTURER
Becton Dickinson & Co., BD Diagnostic Systems, Sparks, MD, by telephone on March 28, 2011 and letter on April 8, 2011. Firm initiated recall is ongoing.
VOLUME OF PRODUCT IN COMMERCE
421 disks
DISTRIBUTION
Nationwide
