Events

Safety Alert for VIDAS Cortisol S

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

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
    2014-10-28
  • Event Date Posted
    2014-10-28
  • Event Country
    Hong Kong
  • Event Source
    DH
  • Event Source URL
    https://www.mdco.gov.hk/english/safety/recalls/recalls_20141028a.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: biomérieux vidas cortisol s medical device manufacturer, biomérieux, has issued a medical device safety alert concerning its vidas cortisol s. the affected product number is 30451 and the affected lot number is 1003380350. an error occurred during the manufacturing process of vidas cortisol s kits (ref. 30451, lot 1003380350). the quantity of one of the raw material present in the composition of the conjugate buffer (well 5 of the vidas cortisol s strips ref. 30451 lot 1003380350). according to the manufacturer, the identified discrepancy does not affect product performance nor does it pose any health and safety risk to the end user. the manufacturer advises users to discard any remaining inventory of the affected products and contact them for product replacement. according to the local supplier, the affected products were distributed in hong kong. if you are in possession of the affected products, please contact your supplier for necessary actions. posted on 28 october 2014.

Device

VIDAS Cortisol S
  • Model / Serial
  • Product Description
    Medical Device Safety Alert: BioMérieux VIDAS Cortisol S
  • Manufacturer
    BioMérieux

Manufacturer

BioMérieux