Events

Recall of REMEL PATHODX STREP GROUP B LATEX

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

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
    114733
  • Event Risk Class
    III
  • Event Initiated Date
    2015-05-15
  • 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
    A technical investigation has confirmed that pathodx strep b latex may produce weak or slow reactions that may result in a failure to identify b-haemolytic streptococci group b isolates potentially leading to a delay in result reporting and/or a delay to delivering appropriate therapy.

Device

REMEL PATHODX STREP GROUP B LATEX
  • Model / Serial
    Model Catalog: R62025 (Lot serial: LOT 1470133); Model Catalog: R62031 (Lot serial: LOT 1463129); Model Catalog: R62025 (Lot serial: LOT 1463129); Model Catalog: R62031 (Lot serial: LOT 1470133)
  • Product Description
    REMEL PATHODX STREP GROUP B LATEX
  • Manufacturer
    OXOID COMPANY

Manufacturer

OXOID COMPANY