Safety Alert for Vitek 2 Gram Positive Susceptibility Test Cards

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

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
  • Event Date Posted
  • Event Country
  • Event Source
  • Event Source URL
  • 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: biomerieux vitek 2 gram positive susceptibility test cards the united states food and drug administration (fda) has issued a medical device safety alert concerning vitek 2 gram positive susceptibility test cards, manufactured by biomerieux. the affected devices are identified as follows:- (ast-p636 ref 417951), (ast-p639 ref 418662), (ast-p640 ref 418579), (ast-p641 ref 418590), (ast-p642 ref 418604), (ast-p643 ref 418671), (ast-p644 ref 418673), (ast-p645 ref 419602), (ast-p646 ref 420144) according to the fda, the product inserts fail to identify performance limitation related to eucast breakpoints for teicolplanin. for details, please refer to the fda website: http://www.Accessdata.Fda.Gov/scripts/ires/index.Cfm if you are in possession of the affected products, please contact your supplier for necessary actions. posted on 18 may 2016.