Events

Recall Or Safety Alert for FluoroType® CT kit (VER 1.0), lot SD00039 (reference 61096, kit for 96 reactions)

According to Agencia Española de Medicamentos y Productos Sanitarios (Via FOI), this recall or safety alert involved a device in Spain that was produced by Hain Lifescience GmbH.

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
    Recall / Safety Alert
  • Date
    2016-09-28
  • Event Country
    Spain
  • Event Source
    AEMPSVFOI
  • Notes / Alerts
    The data from Spain is current through June 2018. All of the data comes from Agencia Española de Medicamentos y Productos Sanitarios, 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 Spain.
  • Extra notes in the data
  • Action
    Cessation of the use of batch SD00039 of the FluoroType® CT kit, manufactured by Hain Lifescience GmbH, Germany, due to a possible reduction of the fluorescence signal.

Device

FluoroType® CT kit (VER 1.0), lot SD00039 (reference 61096, kit for 96 reactions)

Manufacturer

Hain Lifescience GmbH