Events

Recall of DENGUE NS1 AG STRIP

According to Health Canada (via FOI), this recall involved a device in Canada that was produced by BIO-RAD.

What is this?

A correction or removal action taken by a manufacturer to address a problem with a medical device. Recalls occur when a medical device is defective, when it could be a risk to health, or when it is both defective and a risk to health.

Learn more about the data here
  • Type of Event
    Recall
  • Event ID
    50792
  • Event Risk Class
    II
  • Event Initiated Date
    2015-01-06
  • Event Country
    Canada
  • Event Source
    HC
  • Notes / Alerts
    Canadian data is current through March 2018. All of the data comes from Health Canada, 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 recall data from the U.S. and Canada.
  • Extra notes in the data
  • Reason
    An unexpected amount of negative results from supposedly positive patient samples have been received. a sudden and unusual degradation of the sensitivity of these lots has been observed further to a punctual and isolated event.

Device

DENGUE NS1 AG STRIP
  • Model / Serial
    Model Catalog: 70700 (Lot serial: 5F0130)
  • Product Description
    DENGUE NS1 AG STRIP
  • Manufacturer
    BIO-RAD

Manufacturer

BIO-RAD