Events

Safety Alert for Trade name: ADVIA Chemistry Triglicerides Concentrate TRIG_c Technical name: PROGESTERONE Registration number ANVISA: 10345160327; 10345161844; 10345160654 Hazard Class: II Affected Model: 50 determinations; 250 determinations; kit for 100 tests; kit for 200 tests; kit for 600 tests. Affected lot / series numbers: 0

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; 1) Siemens Healthcare Diagnostics Inc. 2) Siemens Healthcare Diagnostics Products Ltd..

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
    2100
  • Date
    2017-01-19
  • 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
    These trials should not be used to report results to patients who are using DHEA supplements. For patients using DHEA supplements, an alternative method should be used to measure Progesterone concentrations, such as Liquid Chromatography - Mass Spectroscopy (LCMS), which is not expected to demonstrate cross-reaction with DHEA-S. However, Siemens Progesterone assays can continue to be used to report results from patients not using DHEA supplements.
  • Reason
    Siemens healthcare diagnostics has confirmed that the presence of dhea-s (a dhea metabolite, a steroid hormone that is used as part of in vitro fertilization (ivf) protocols to increase the ovarian response and in treatment results) causes falsely elevated results for the progesterone trials listed in the "product data" annex, close to the clinically important decision level of progesterone.
  • Action
    Field Action Code CC 17-06 triggered under the responsibility of the company Siemens Healthcare Diagnósticos SA Company will send letter to the client.

Device

Trade name: ADVIA Chemistry Triglicerides Concentrate TRIG_c Technical name: PROGESTERONE Registr...

Manufacturer

Siemens Healthcare Diagnósticos S.A; 1) Siemens Healthcare Diagnostics Inc. 2) Siemens Healthcare...
  • Manufacturer Parent Company (2017)
    Siemens Ag
  • Source
    ANVSANVISA