Events

Recall of QUANTA FLASH DSDNA CONTROLS

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
    138842
  • Event Risk Class
    III
  • Event Initiated Date
    2016-02-02
  • 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 barcode on the quality control certificate that accompanies the product provides the incorrect control name when using the barcode scanner to add a new lot of controls. the barcode on the certificate does not match the control tube labels. the quality control tube labels display the correct description "l" and "h" for the low control and high control respectively while the quality control certificate indicates the incorrect control names "dsdnan" for the negative control and "dsdnap" for the positive control. users are still able to use the controls but will need to manually enter the correct control name.

Device

QUANTA FLASH DSDNA CONTROLS
  • Model / Serial
    Model Catalog: 701177 (Lot serial: 151012)
  • Product Description
    QUANTA FLASH DSDNA CONTROLS
  • Manufacturer
    INTER MEDICO

Manufacturer

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