Events

Safety Alert for BD BBL Fildes Enrichment

According to Department of Health, this safety alert involved a device in Hong Kong that was produced by BB 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
    2013-01-17
  • Event Date Posted
    2013-01-17
  • Event Country
    Hong Kong
  • Event Source
    DH
  • Event Source URL
    https://www.mdco.gov.hk/english/safety/recalls/recalls_20130117.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 fildes enrichment medical device manufacturer, bb diagnostic systems, has initiated a field safety corrective action concerning bd bbl fildes enrichment [catalogue no.: 211866; lot no.: 2079066, 2096375, 2216092, 2227271]. the manufacturer has determined through complaint investigation that the above-referenced lot numbers of product are failing to support the growth of haemophilus species. the affected users are advised to discontinue use and discard any remaining products. due to an anticipated delay for the available of fildes enrichment, the manufacturer will substitute difco supplement b with reconstituting fluid (catalogue no. 227610-6 x 10ml) as the replacement product. according to the local supplier, the affected products were distributed in hong kong. if you are in possession of the product, please contact your supplier for necessary actions. posted on 17 january 2013.

Device

BD BBL Fildes Enrichment
  • Model / Serial
  • Product Description
    Medical Device Safety Alert: BD BBL Fildes Enrichment
  • Manufacturer
    BB Diagnostic Systems

Manufacturer

BB Diagnostic Systems