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
    2013-04-16
  • Event Date Posted
    2013-04-16
  • Event Country
    Hong Kong
  • Event Source
    DH
  • Event Source URL
    https://www.mdco.gov.hk/english/safety/recalls/recalls_20130416b.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: biomerieux vidas d-dimer exclusion ii medical device manufacturer, biomerieux, has issued a field safety notice concerning the vidas d-dimer exclusion ii [reference no.: 30455 and 30455-01]. the manufacturer has registered some customer complaints about not reproducible results below the detection limit (<45 ng/ml) on the above listed lot numbers. the manufacturer’s internal investigation after testing in-house titrated samples has not reproduced this result. the potential risk associated to this issue is reporting false negative results for vidas d-dimer exclusion ii. the impact of a false negative d-dimer test result could be critical for the patient with a low or moderate clinical pretest probability for deep vein thrombosis (dvt) or pulmonary embolism (pe) because it could prevent further diagnostic workup for venous thromboembolism and withholding anticoagulant treatment when it is actually needed, resulting in a negative impact to patient care. the manufacturer advises all affected users to take the following actions:- repeat all results less than < 45 ng/ml obtained with the kit vidas® d-dimer exclusion ii™ ref. 30455 and 30455-01. determine if retrospective analysis of results of the patients is required and investigate further (e.G. final diagnosis and clinical status of the patient) if the result is < 45 ng/ml. an additional insert will be added to newly manufactured lots to require a confirmation of the results below the detection limit (< 45 ng/ml). according to the local supplier, the affected devices were distributed in hong kong. if you are in possession of the affected products, please contact your supplier for necessary actions. posted on 16 april 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