Events

Safety Alert for REVISION DATE OF REVISION DIMENSION® Technical Name: REVISED IRRIGATION REAGENT - DIMENSION® ANVISA Registration Number: 10345161043 Hazard Class: II Affected Model: Affected Lot / Series Numbers: BA7006, BA7116, BB7006, DB6267, FD6309 , GB7060

According to Agência Nacional de Vigilância Sanitária (ANVISA), this safety alert involved a device in Brazil that was produced by Siemens Healthcare Diagnósticos S.A; 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
    Safety alert
  • Event ID
    2095
  • Date
    2016-09-30
  • Event Country
    Brazil
  • Event Source
    ANVISA
  • Event Source URL
    http://www.anvisa.gov.br/sistec/alerta/consultaralerta.asp
  • Notes / Alerts
    Brazilian data is current through June 2018. All of the data comes from Anvisa, 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 Brazil.
  • Extra notes in the data
    If users receive any complaints of illness or adverse events associated with the product, they should immediately contact the Siemens Customer Support Center or the Siemens technical support representative in their locality.
  • Reason
    Iron dimension and dimension wear a concentration other than that listed in the instructions for use. deferoxamine is cited in the directions for use dimension and dimension vista as a non-interfering substance. the concentration that was used for interference tests (250 ng / dl or 3.8 nmol / l) is significantly lower than expected in clinical practice. siemens healthcare diagnostics sa is providing an update in the section limitations of the instructions for use procedure, iron test for dimension and dimension vista systems, indicating that: patients treated with drugs that bind to metals (eg deferoxamine) may present a reduction in values iron, since the chelating iron may not react adequately in this test. the reference to deferoxamine at a concentration of 250 ng / dl (3.8 nmol / l) will be removed from the section "non-interfering substances" in the instructions for use. the information provided in this release, related to deferoxamine, replaces the information contained on this substance in the current ferro operating instructions for the dimension and dimension vista systems until their respective operating instructions are updated.
  • Action
    Field Action Code VC 16-07 triggered under the responsibility of the company Siemens Healthcare Diagnósticos SA Company will send Letter to the Client.

Device

REVISION DATE OF REVISION DIMENSION® Technical Name: REVISED IRRIGATION REAGENT - DIMENSION® ANVI...

Manufacturer

Siemens Healthcare Diagnósticos S.A; Siemens Healthcare Diagnostics Inc.
  • Manufacturer Parent Company (2017)
    Siemens Ag
  • Source
    ANVSANVISA