Events

Safety Alert for BD BBL DrySlide PYR Kit and BD BBL DrySlide Oxidase Kit

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

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
    2013-04-26
  • Event Date Posted
    2013-04-26
  • Event Country
    Hong Kong
  • Event Source
    DH
  • Event Source URL
    https://www.mdco.gov.hk/english/safety/recalls/recalls_20130426c.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 dryslide pyr kit and bd bbl dryslide oxidase kit medical device manufacturer, bd, has issued a field safety notice concerning bbl dryslide pyr kit (catalogue number: 231747, lot number: 2276481) and bbl dryslide oxidase kit (catalogue number: 231746, lot number: 2222008). bd has confirmed through complaint investigation that during the manufacturing process portions of the test slides in the above referenced products were placed into the incorrect product packaging. this could result in intermittent quality control failures and false results. the manufacturer advises to discontinue and discard affected products and product replacement can be arranged. according to the local supplier, the affected products were distributed in hong kong. if you are in possession of the products, please contact your supplier for necessary actions. posted on 26 april 2013.

Device

BD BBL DrySlide PYR Kit and BD BBL DrySlide Oxidase Kit
  • Model / Serial
  • Product Description
    Medical Device Safety Alert: BD BBL DrySlide PYR Kit and BD BBL DrySlide Oxidase Kit
  • Manufacturer
    BD

Manufacturer

BD