Events

Recall of XPERT GBS 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
    52989
  • Event Risk Class
    II
  • Event Initiated Date
    2017-12-07
  • 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
    High number of pressure abort (e2008) errors observed in the field when using gxgbs-100n-10 lots 08006 08007 08008 08009 08010 08011 08012 08401 08402 08403 08404 08405 08406 08407 08408 08409 08410 09201 and 09202.

Device

XPERT GBS ASSAY
  • Model / Serial
    Model Catalog: GXGBS-100N-10 (Lot serial: Batch 1000041037 (lot 08008)); Model Catalog: GXGBS-100N-10 (Lot serial: Batch 1000054881 (lot 08405))
  • Product Description
    XPERT GBS Assay
  • Manufacturer
    CEPHEID

Manufacturer

CEPHEID