Events

Field Safety Notices about RightSign HIV 1.2.O Rapid Test Cassette, HCV Rapid Test Cassette & HBsAg Rapid Test Cassette

According to Health Products Regulatory Authority, this field safety notices involved a device in Ireland that was produced by Hangzhou Biotest Biotech Co. Ltd..

What is this?

Field safety notices are communications sent out by medical device manufacturers or their representatives in relation to actions that they may be taking in relation to their product that is on the market. These are mainly for health workers, but also for users. They can include recalls and alerts.

Learn more about the data here
  • Type of Event
    Field Safety Notice
  • Event Number
    SN2016(16)
  • Date
    2016-06-20
  • Event Country
    Ireland
  • Event Source
    HPRA
  • Event Source URL
    http://www.hpra.ie/homepage/medical-devices/safety-information/safety-notices/item?t=/SN201616&id=29860626-9782-6eee-9b55-ff00008c97d0
  • Notes / Alerts
    "Irish data is current through April 2019. All of the data comes from the Health Products Regulatory Authority (Ireland), 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 Ireland."
  • Extra notes in the data

Device

RightSign HIV 1.2.O Rapid Test Cassette, HCV Rapid Test Cassette & HBsAg Rapid Test Cassette
  • Model / Serial
  • Product Description
    RightSign HIV 1.2.O Rapid Test Cassette, HCV Rapid Test Cassette & HBsAg Rapid Test Cassette. Priority 2 – Warning
  • Manufacturer
    Hangzhou Biotest Biotech Co. Ltd.

Manufacturer

Hangzhou Biotest Biotech Co. Ltd.