Events

Recall Or Safety Alert for Molecular System VERSANT kPCR, material number Siemens 10282928. Affected assays: VERSANT® HIV-1 RNA 1.5 (kPCR), VERSANT® HBV DNA 1.0 (kPCR), VERSANT® HCV RNA 1.0 (kPCR), VERSANT® CT / GC DNA 1.0 (kPCR)

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
    2016-04-19
  • 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 when certain assays are processed in the molecular systems VERSANT kPCR, manufactured by Siemens Healthcare Diagnostics, Inc., USA, a result is not reported as "Invalid result" when the internal control for that well is invalidated by a "No Baseline error. "

Device

Molecular System VERSANT kPCR, material number Siemens 10282928. Affected assays: VERSANT® HIV-1 ...

Manufacturer

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