Events

Safety Alert for VIDAS D-Dimer Exclusion II

According to Department of Health, this safety alert involved a device in Hong Kong that was produced by Biomerieux.

What is this?

Alerts provide important information and recommendations about products. Even though an alert has been issued, it does not necessarily mean a product is considered to be unsafe. Safety Alerts, addressed to health workers and users, may include recalls. They can be written by manufacturers, but also by health officials.

Learn more about the data here
  • Type of Event
    Safety alert
  • Date
    2013-01-23
  • Event Date Posted
    2013-01-23
  • Event Country
    Hong Kong
  • Event Source
    DH
  • Event Source URL
    https://www.mdco.gov.hk/english/safety/recalls/recalls_20130123a.html
  • Notes / Alerts
    Hong Kong data is current through September 2018. All of the data comes from the Department of Health (Hong Kong), 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 data from the U.S. and Hong Kong.
  • Extra notes in the data
    Medical Device Safety Alert
  • Reason
    Medical device safety alert: biomérieux vidas d-dimer exclusion ii health canada has posted a medical device safety alert concerning vidas d-dimer exclusion ii manufactured by biomérieux. the affected model/catalogue and lot/serial numbers are 30455 and 1001399220 respectively. the manufacturer has registered two complaints on false negative results under the detection limit (<45 ng/ml) using the batch 1001399220. the investigation indicates that there is the potential for a manufacturing issue to be the cause of the problem and root cause investigations are in-process. the impact of a false negative d-dimer test result could be critical for the patient because it could prevent further diagnostic workup for venous thromboembolism and withhold anticoagulant treatment when it is actually needed, resulting in a negative impact to patient care. as a preventive measure, biomérieux has decided to remove the suspect product from the field. furthermore, all affected users are advised to take the following necessary actions: stop using and destroy the affected products. perform a retrospective analysis of the patients tested on this batch and investigate further (e.G. final diagnosis and clinical status of the patient) if the result is < 45 ng/ml. according to the local supplier, the affected products are distributed in hong kong. for details, please visit the following health canada website: http://www.Hc-sc.Gc.Ca/dhp-mps/compli-conform/recall-retrait/_list/ rec-ret_md-im_date_jan-mar_2013-eng.Php if you are in possession of the product, please contact your supplier for necessary actions. posted on 23 january 2013.

Device

VIDAS D-Dimer Exclusion II
  • Model / Serial
  • Product Description
    Medical Device Safety Alert: Biomerieux VIDAS D-Dimer Exclusion II
  • Manufacturer
    Biomerieux

Manufacturer

Biomerieux