Events

Safety Alert for THERMO LABSYSTEMS. MODEL 65500, (6) MODEL 65400, (6) MODEL 65500, (6) MODEL 65500, (6). PHOTOMETRIC, MICROPLATE READING. ANALYZERS, LABORATORY, IMMUNOASSAY, PHOTOMETRIC, MICROPLATE READING

According to Agência Nacional de Vigilância Sanitária (ANVISA), this safety alert involved a device in Brazil that was produced by THERMO LABSYSTEMS OY (US) A THERMO ELECTRON CO; DYNEX TECHNOLOGIES INC SUB THERMO BIOANALYSIS CORP.

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
    64
  • Date
    2001-05-23
  • 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
    UNTIL THIS DATE DOES NOT CONSERT PRODUCT REGISTRATION IN BRAZIL
  • Reason
    An incorrect sample volume may be released, taking a wrong result of the test in the analyzers mentioned. in addition, an electromagnetic incompatibility can make that the above analyzers report an error and travem. the manufacturer started a recall through correspondence sent on april 18, 2001.
  • Action
    MAKE SURE YOU HAVE RECEIVED THE CORRESPONDENCE OF APRIL 18, 2001, SUBMITTED BY THERMO LABSYSTEMS OR DYNEX TECHNOLOGIES. IDENTIFY AND ISOLATE THE AFFECTED SYSTEM IN YOUR STOCK. FOR FURTHER INFORMATION, CONTACT THERMO LABSYSTEMS BY TEL. (800) 522-7763 WITHIN THE US OR BY TEL. (508) 541-0439 OUTSIDE THE USA.

Device

THERMO LABSYSTEMS. MODEL 65500, (6) MODEL 65400, (6) MODEL 65500, (6) MODEL 65500, (6). PHOTOMETR...

Manufacturer

THERMO LABSYSTEMS OY (US) A THERMO ELECTRON CO; DYNEX TECHNOLOGIES INC SUB THERMO BIOANALYSIS CORP
  • Source
    ANVSANVISA