Events

Safety Alert for BD BBL Crystal Enteric/Nonfermenter ID Kit

According to Department of Health, this safety alert involved a device in Hong Kong that was produced by BD Diagnostic Systems.

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
    Safety alert
  • Date
    2012-12-28
  • Event Date Posted
    2012-12-28
  • Event Country
    Hong Kong
  • Event Source
    DH
  • Event Source URL
    https://www.mdco.gov.hk/english/safety/recalls/recalls_20121228.html
  • Notes / Alerts
    Hong Kong data is current through September 2018. All of the data comes from the Department of Health (Hong Kong), 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 Hong Kong.
  • Extra notes in the data
    Medical Device Safety Alert
  • Reason
    Medical device safety alert: bd bbl crystal enteric/nonfermenter id kit medical device manufacturer, bd diagnostic systems, has issued a medical device safety alert concerning bbl crystal enteric/nonfermenter id kit. the affected catalogue number is 245000 and the affected lot numbers are 2086315, 2101435, 2104316, 2129460, 2129487, 2163211, 2163213, and 2163215. bd has determined through complaint investigation that the above referenced products have the citrate (cit) and malonic acid (mlo) reagents in the reversed prong/well positions. this may lead to no-identification or multiple identification choices. customers specifically reported split identification results between citrobacter and salmonella; however, other bacterial identifications requiring the use of these two substrates may also be affected. according to the local supplier, the affected products have been distributed in hong kong. bd advised the affected customers to discontinue use of the affected lots and discard any remaining packages. if you are in possession of the products, please contact your supplier for necessary actions. posted on 28 december 2012.

Device

BD BBL Crystal Enteric/Nonfermenter ID Kit
  • Model / Serial
  • Product Description
    Medical Device Safety Alert: BD BBL Crystal Enteric/Nonfermenter ID Kit
  • Manufacturer
    BD Diagnostic Systems

Manufacturer

BD Diagnostic Systems