Events

Recall of BD PROBETEC ET - CHLAMYDIA TRACHMOMATIS NEISSERIA GONORRHOEAE REAGENT PACK

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

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
    66513
  • Event Risk Class
    II
  • Event Initiated Date
    2010-10-01
  • 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
    When tested in conjunction with bd probetec ct/gc positive control returned strips from full and partially used ct microwell pairs from the indicated bd probetec ct/gc/ac reagent pack batches yield invalid ct positive control results.

Device

BD PROBETEC ET - CHLAMYDIA TRACHMOMATIS NEISSERIA GONORRHOEAE REAGENT PACK
  • Model / Serial
    Model Catalog: 440450 (Lot serial: batch 0158908)
  • Product Description
    BD PROBETEC CT GC AC REAGENT PACK
  • Manufacturer
    BECTON DICKINSON CANADA INC.

Manufacturer

BECTON DICKINSON CANADA INC.