Events

Safety Alert for ADVIA CENTAUR TSH3-Ultra (TSH3-UL) - Registration No. 10345161732 ;. REAGENT FLEX TSH DIMENSION - Registration No. 10345161255 ;. TSH THIRD GENERATION IMMULITE / IMMULITE 1000 - Registration No. 10345160833 ;. TSH 3rd GENERATION IMMULITE 2000 - Registration No. 10345160834

According to Agência Nacional de Vigilância Sanitária (ANVISA), this safety alert involved a device in Brazil 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
    Safety alert
  • Event ID
    1273
  • Date
    2013-07-18
  • 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
    See the instructions for use of each product for more information. Consult the National Academy of Clinical Biochemistry: Laboratory Support for the Diagnosis and Monitoring of Thyroid Diseases: Guide # 18 for additional information on investigations of discordant TSH values. If you have any questions or need additional information, please contact the Customer Support Center at 0800-129-633. Link: Letter to the customer - http://portal.anvisa.gov.br/wps/wcm/connect/1ba0a0004066b7f78293d2dc5a12ff52/Carta_CC_13_06.pdf?MOD=AJPERES
  • Reason
    A rare variant of tsh, identified in a small group of patients, is not detected by the following siemens assays: advia centaur® systems tsh3 ultra 100t, 500t, 2500t; dimension® thyroid stimulating hormone; dimension loci® thyroid stimulating hormone; immulite® systems third generation tsh 100t, 500t; immulite® 2000 / immulite® 2000 xpi third generation tsh 200t, 600t; immulite systems rapid tsh 100t, 500t; immulite 2000 / immulite 2000 xpi rapid tsh 200t, 600t.
  • Action
    Siemens Healthcare Diagnostics is informing its customers

Device

ADVIA CENTAUR TSH3-Ultra (TSH3-UL) - Registration No. 10345161732 ;. REAGENT FLEX TSH DIMENSION -...

Manufacturer

Siemens Healthcare Diagnostics Inc.
  • Manufacturer Parent Company (2017)
    Siemens Ag
  • Source
    ANVSANVISA