Events

Recall Or Safety Alert for Typing kit LIFECODES HLA-DQA1 / B1 reference 628930, lots 11184C and 07065B.

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 Transplant Diagnostics.

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
    2016-02-05
  • 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
    Possibility that the LIFECODES HLA-DQA1 / B1 typing kit, manufactured by Immucor Transplant Diagnostics, USA, is incorrectly typing the DQB1 * 03: 03: 02: 01, DQB1 * 03: 04: 01 as DQB1 * 03 : 01: 01: 01, DQB1 * 03: 02: 01, due to a false positive from the DQB253 probe.

Device

Typing kit LIFECODES HLA-DQA1 / B1 reference 628930, lots 11184C and 07065B.

Manufacturer

Transplant Diagnostics
  • Source
    AEMPSVFOI