Events

Recall of ACCUPROBE MYCOBACTERIUM TUBERCULOSIS COMPLEX (TB COMPLEX) KIT

According to Health Canada (via FOI), this recall involved a device in Canada that was produced by GEN-PROBE INCORPORATED DOING BUSINESS AS HOLOGIC 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
    155362
  • Event Risk Class
    III
  • Event Initiated Date
    2009-01-16
  • 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
    Recall was initiated in response to a customer complaint leading to the detection that a small number of probe vials in each kit may be empty (do not contain probe reagent) or may not contain labelled amount. testing with these tubes would yield a false negative result.

Device

ACCUPROBE MYCOBACTERIUM TUBERCULOSIS COMPLEX (TB COMPLEX) KIT
  • Model / Serial
    Model Catalog: (Lot serial: Batch # 554628); Model Catalog: (Lot serial: Batch # 555767); Model Catalog: (Lot serial: Batch # 555170); Model Catalog: (Lot serial: Batch # 556204)
  • Product Description
    ACCUPROBE Mycobacterium TB Complex Kit
  • Manufacturer
    GEN-PROBE INCORPORATED DOING BUSINESS AS HOLOGIC INC.

Manufacturer

GEN-PROBE INCORPORATED DOING BUSINESS AS HOLOGIC INC.
  • Manufacturer Address
    SAN DIEGO
  • Manufacturer Parent Company (2017)
    Hologic, Inc.
  • Source
    HC