Events

Recall of CORTISOL SALIVA LUMINESCENCE IMMUNOASSAY

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

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
    40457
  • Event Risk Class
    III
  • Event Initiated Date
    2018-01-12
  • 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
    Ibl detected an issue that indicates a degradation in performance of the kit that results in elevated cortisol values. when testing patient samples with one of the affected lots the controls and calibrator values will meet specifications.

Device

CORTISOL SALIVA LUMINESCENCE IMMUNOASSAY
  • Model / Serial
    Model Catalog: RE62119 (Lot serial: LCL 130); Model Catalog: RE62111 (Lot serial: LCL 130); Model Catalog: RE62111 (Lot serial: LCL 134); Model Catalog: RE62119 (Lot serial: LCL 134)
  • Product Description
    CORTISOL SALIVA LUMINESCENCE IMMUNOASSAY
  • Manufacturer
    IBL INTERNATIONAL GMBH

Manufacturer

IBL INTERNATIONAL GMBH
  • Manufacturer Address
    HAMBURG
  • Manufacturer Parent Company (2017)
    Tecan Group AG
  • Source
    HC