Events

Safety Alert for VIDAS 3 system

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
    2013-12-23
  • Event Date Posted
    2013-12-23
  • Event Country
    Hong Kong
  • Event Source
    DH
  • Event Source URL
    https://www.mdco.gov.hk/english/safety/recalls/recalls_20131223.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 3 system medical device manufacturer, biomérieux, has issued a medical device safety alert concerning its vidas 3 system [catalogue number: 412590]. the manufacturer was informed that some customers experienced pipetting issue on the instrument vidas 3 ref. 412590 when they use tubes with an external diameter of around 12 mm. the issue is due to a collision between a small flat step at the top of the tip and the tube edges when the pipettor is going down to aspirate in the tube. the instrument identifies the problem and errors 0956 xapu and/or 0502 (loading bay errors) happen. there is no risk to have an incorrect diagnostic because the error message will occur before having a diagnostic result. the manufacturer advises users to stop using the tubes size of 12 mm and to use tubes with a larger diameter (13 and/or 16 mm as per user manual) until corrective actions are implemented. the user manual will be updated based on the investigation results. 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 23 december 2013.

Device

VIDAS 3 system
  • Model / Serial
  • Product Description
    Medical Device Safety Alert: BioMérieux VIDAS 3 system
  • Manufacturer
    BioMérieux

Manufacturer

BioMérieux