Events

Safety Alert for IH-1000

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

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
    2013-06-17
  • Event Date Posted
    2013-06-17
  • Event Country
    Hong Kong
  • Event Source
    DH
  • Event Source URL
    https://www.mdco.gov.hk/english/safety/recalls/recalls_20130617.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: bio-rad ih-1000 the australia therapeutic goods administration (tga) has posted a medical device safety alert concerning ih-1000, manufactured by bio-rad. the affected product reference number is 001000 and all software versions are affected. in some specific conditions, inconsistent grading between the results in the well/card and the results returned by the ih-1000 may be observed. in these very specific conditions, positive reactions might be read as negative by the system due to the analysis algorithm of the images. therefore, this issue might lead to a wrong result released to the host if the 3 following conditions are met: a result is returned as negative while the reaction is positive, double population, or requires a human interpretation and, this negative result is consistent with the global interpretation of the test and, the system is configured without the second reading function activated for all tests results. the manufacturer is providing work around instructions as an interim measure. a software update will be implemented to permanently correct the issue. for details, please visit the following tga website: http://www.Tga.Gov.Au/sara/arn-detail.Aspx?k=rc-2013-rn-00593-1 if you are in possession of the affected products, please contact your supplier for necessary actions. posted on 17 june 2013.

Device

IH-1000
  • Model / Serial
  • Product Description
    Medical Device Safety Alert: Bio-Rad IH-1000
  • Manufacturer
    Bio-Rad

Manufacturer

Bio-Rad