Events

Recall of NOVA GEL T SS-A/SS-B

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

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
    24347
  • Event Risk Class
    III
  • Event Initiated Date
    2013-09-06
  • 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
    As a result of the investigation of a complaint regarding the product mentioned above the manufacturer inova diagnostics has confirmed that there is no visible precipitin line that develops between the ss-b positive control well and the ss-b antigen well on the nova gel plate within the expected 24 to 48 hour timeframe. this would result in an invalid test result and therefore no results would be reported.

Device

NOVA GEL T SS-A/SS-B
  • Model / Serial
    Model Catalog: 708455 (Lot serial: 003048)
  • Product Description
    NOVA GEL SS-A/SS-B "T"
  • Manufacturer
    INTER MEDICO

Manufacturer

INTER MEDICO
  • Manufacturer Address
    MARKHAM
  • Manufacturer Parent Company (2017)
    Inter Medico
  • Source
    HC