Events

Recall of ROTA-STRIP TEST KIT

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

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
    56461
  • Event Risk Class
    III
  • Event Initiated Date
    2014-09-17
  • 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
    The intensity of the rotavirus test line signals generated by the incriminated rota positive control could be judged too weak. as a consequence one may erroneously conclude that the tested diagnostic kit quality is beyond the expectations and that weak positive signals could be missed with clinical samples.

Device

ROTA-STRIP TEST KIT
  • Model / Serial
    Model Catalog: C-1081 (Lot serial: BATCH #1081G1408)
  • Product Description
    ROTA-STRIP TEST KIT
  • Manufacturer
    CORIS BIOCONCEPT

Manufacturer

CORIS BIOCONCEPT