Events

Recall of ANTI-SACCHAROMYCES CEREVISIAE ANTIBODIES (ASCA) IGA TEST

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

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
    133383
  • Event Risk Class
    II
  • Event Initiated Date
    2017-06-23
  • 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
    It has been observed recently that the values of some samples tested with the autoimmune eia asca iga test decreased significantly when compared to the values of the same set of samples tested with another lot of autoimmune eia asca iga test. this observation was confirmed by subsequent testing with a different set of samples. the observed decrease in sample value presents a potential for increase in false negative results.

Device

ANTI-SACCHAROMYCES CEREVISIAE ANTIBODIES (ASCA) IGA TEST
  • Model / Serial
    Model Catalog: 4252320 (Lot serial: 16325A)
  • Product Description
    ANTI-SACCHAROMYCES CEREVISIAE ANTIBODIES (ASCA) IGA TEST
  • Manufacturer
    BIO-RAD LABORATORIES (CANADA) LTD.

Manufacturer

BIO-RAD LABORATORIES (CANADA) LTD.