Events

Recall of GENEXPERT DX SYSTEM - XPERT MRSA ASSAY

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

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
    72434
  • Event Risk Class
    II
  • Event Initiated Date
    2017-11-27
  • 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
    Some customers have experienced a higher number of invalid results than would typically be expected when using this test and its intended use specimen types.

Device

GENEXPERT DX SYSTEM - XPERT MRSA ASSAY
  • Model / Serial
    Model Catalog: GXMRSA-100N-10 (Lot serial: Batch 1000054536 (lot 20712))
  • Product Description
    XPERT MRSA ASSAY
  • Manufacturer
    CEPHEID

Manufacturer

CEPHEID