Events

Safety Alert for Ebola Virus One Step Test Kits

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

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
    2015-04-17
  • Event Date Posted
    2015-04-17
  • Event Country
    Hong Kong
  • Event Source
    DH
  • Event Source URL
    https://www.mdco.gov.hk/english/safety/recalls/recalls_20150417a.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: lusys laboratories ebola virus one step test kits the united states food and drug administration (fda) has issued medical device safety alerts concerning various ebola virus one step test kits, manufactured by lusys laboratories, inc. the affected devices are identified as follow:- ebola virus antigen blood, catalog no. i-123 (a). ebola virus gp-vp igs, catalog no. i-124. ebola accessories assembled, self-contained package, catalog no. i-104. [lot no. dei007963] ebola virus antigen nasal , catalog no. i-123 (b). [lot no. 12292014b] ebola igx vp-40 serum/plasma/blood cassette, catalog no. i-100. [lot no. 12012014b] ebola gp igx blood, serum, plasma, cassette, catalog no. i-101. [lot no. 12012014b] ebola gp igm blood (blood serum/plasma/cassette), catalog no. i-103. [lot no. 12012014a] ebola vp-40 igg/igm (blood serum/plasma/cassette), catalog no. i-102.[lot no. 11192014b] the manufacturer is recalling the above ebola virus test kits as they have not yet been cleared, approved or authorised by the fda for diagnostics purposes. for details, please refer to the fda website: http://www.Accessdata.Fda.Gov/scripts/enforcement/enforce_rpt-event-detail.Cfm?action=detail&id=70668&w=04152015%e2%8c%a9=eng if you are in possession of the affected products, please contact your supplier for necessary actions. posted on 17 april 2015.

Device

Ebola Virus One Step Test Kits
  • Model / Serial
  • Product Description
    Medical Device Safety Alert: LuSys Laboratories Ebola Virus One Step Test Kits
  • Manufacturer
    LuSys Laboratories

Manufacturer

LuSys Laboratories