Events

Recall Or Safety Alert for Lot 15243M of the Dimension Vista® Flex HCYS Reagent Cartridge ", catalog number K7044, material number Siemens (SMN) 15243MA

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 Siemens Healthcare Diagnostics Inc.

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
    2016-06-06
  • 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 use of batch 15243M of the reagent cartridge "Dimension Vista® Flex HCYS", manufactured by Siemens Healthcare Diagnostics Inc, USA, because it shows a reduced open well stability that could give rise to invalid series.

Device

Lot 15243M of the Dimension Vista® Flex HCYS Reagent Cartridge ", catalog number K7044, material ...

Manufacturer

Siemens Healthcare Diagnostics Inc
  • Manufacturer Parent Company (2017)
    Siemens AG
  • Source
    AEMPSVFOI