Recall Or Safety Alert for BBL(TM) MGIT(TM) Mycobacteria Growth Indicator Tube

According to Central Drugs Standard Control Organization, this recall or safety alert involved a device in India that was produced by Becton Dickinson and Company.

What is this?

Alerts provide important information and recommendations about products. Even though an alert has been issued, it does not necessarily mean a product is considered to be unsafe. Safety Alerts, addressed to health workers and users, may include recalls. They can be written by manufacturers, but also by health officials.

Learn more about the data here
  • Type of Event
    Recall / Safety Alert
  • Event ID
    1-B-1-N-2010-DC(01) End. 04
  • Date
    2013-12-10
  • Event Country
  • Event Source
    CDSCO
  • Event Source URL
  • Notes / Alerts
    The data from India is current through 2017. All of the data comes from the Central Drugs Standard Control Organization, 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 recall data from the U.S. and India.
  • Extra notes in the data
  • Reason
    Voluntary recall of the bbl™ mgit™ mycobacteria growth indicator tube (lot no. 3042467) due to a portion of tubes of the product contain an incorrect prefix on the barcode label. the incorrect prefix begins with "43 02" instead of the required "43 01". the instrument bactec™ mgit may report an incorrect result for growth and detection function.
  • Action
    - Do not use the BBL™ MGIT™ Mycobacteria Growth Indicator Tube (lot No. 3042467) - Retum all unused product to the manufacturer.

Manufacturer