Device Recall BACTEC(tm) MGIT(tm) AST Starter Kit, 의 리콜

not coded

Immunology and Microbiology Devices

2

No

Worldwide Distribution - USA including CA, MA, MD, VA and the countries of Argentina, Colombia, Belgium, China, India, Hong Kong, Peru, Singapore, Thailand, and Trinidad.

BACTEC(tm) MGIT(tm) AST Starter Kit, Catalog 445941. Kit contains 16 each of the 5-Tube and 2-Tube Set Carriers. ***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.