Events

Safety Alert for ADVIA Chemistry Triglicerides Concentrate TRIG_c Technical Name: TRIGLYCERID ANVISA Registration Number: 10345161948 Hazard Class: II Affected Model: 4 vials x 40 mL Affected lot / series numbers: 365096, 379919

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
    2099
  • Date
    2016-09-21
  • 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
    Siemens recommends discontinuing use and discarding lot kit 365096 and 379597. Other lots (379919, 379930, 379942, 379946 and 376894) should be discarded when they reach the revised shelf life.
  • Reason
    Siemens healthcare diagnostics has confirmed that the triglyceride concentrate reagent (trig_c) advia® chemistry does not correspond to the linearity quoted in the instructions for use (ifu) for the upper limit of the assay when the reagent is close to expiration.
  • Action
    Field Action Code CHC 16-03A triggered under the responsibility of the company Siemens Healthcare Diagnósticos SA Company will notify the client.

Device

ADVIA Chemistry Triglicerides Concentrate TRIG_c Technical Name: TRIGLYCERID ANVISA Registration ...

Manufacturer

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