Events

Recall of ANTI-DS DNA KIT

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

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
    110102
  • Event Risk Class
    III
  • Event Initiated Date
    2015-04-10
  • 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
    Specific product codes for the anti-dsdna kit were omitted in error. this means that customers have received the correct products due to the omission of the product code on the outer box it is not clearly identifiable if they have received the 50 tests version (im77 lot c323026) or 100 tests version (im771 lot c323027). the kits may be differentiated by the lot numbers printed on the outer box. the individual component labelling within the kit has not been affected. also the tracer and ammonium sulphate solution lot numbers were omitted for these particular lots of product.

Device

ANTI-DS DNA KIT
  • Model / Serial
    Model Catalog: IM771 (Lot serial: C323027)
  • Product Description
    Anti-DS DNA KIT
  • Manufacturer
    PRO-LAB DIAGNOSTICS

Manufacturer

PRO-LAB DIAGNOSTICS