BBL MGIT Mycobacteria Indicator Tube (reg 10033430437), BBL MGIT 960 PZA Medium (reg 10033430381), BBL MGIT Mycobacteria Growth Indicator Tube (reg 10033430437). 의 안전성 경고

Brazilian data is current through June 2018. All of the data comes from Anvisa, except for the categories Manufacturer Parent Company and Product Classification.
The Parent Company and the Product Classification were added by ICIJ.
The parent company information is based on 2017 public records. The device classification information comes from FDA’s Product Classification by Review Panel, based on matches of data from the U.S. and Brazil.

The manufacturer of the products in the United States of America, Becton Dickinson and Company, received a limited number of complaints (5 complaints between 2003 and 2008) reporting the presence of cracks in culture media tubes for mycobacteria detection. In only one case was found leaking of the medium after inoculation. Becton Dickinson cautions against the fact that pathogenic microorganisms, including hepatitis B virus and acquired immunodeficiency virus (HIV), may be present in clinical samples, which makes the presence of cracking in the tubes of these products a risk factor for the user. According to the company, before using culture medium vials, the user should carefully examine the vials for evidence of contamination or damage - if any problem is verified, the tube should be discarded immediately. The Technovigilance Unit is following up on this case.