Events

Safety Alert for Modular Analyzers of Clinical Chemistry based on Immunological Assays: (1) Model E170, (2) Integrated Model E170. Catalog No.: 7656961, 7657009, 7657021, 7657900; all serial numbers.

According to Agência Nacional de Vigilância Sanitária (ANVISA), this safety alert involved a device in Brazil that was produced by Roche Diagnostics Corp [391899], 9115 Hague Rd, Indianapolis IN 46256 (distribuidor); Hitachi Ltd Ibaraki-Ken 312-8504, Japan (fabricante).

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
    692
  • Date
    2003-03-07
  • 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
    Liquid may leak from the above mentioned analyzers, which may cause smoke) and / or damage to the units. the distributor notified by letter dated 18 october 2002.
  • Action
    Make sure you received the Roche letter on October 18, 2002. Identify any affected product in your inventory. Until assembly / adjustment is complete, if you see or smell smoke, immediately turn off the system at the main switch, and call the Roche Technical Support Center. For additional information, schedule a technical visit in your area, and to arrange the units in your inventory, contact your local Roche representative. ANVISA has provided the Occurrence Notification Forms on the Internet http://www.anvisa.gov.br/sistec/notificacaoavulsa/notificacaoavulsa1.asp so that you notify if there are any problems with the products in your inventory. For further information, please contact ANVISA's Tecnovigilância Unit, by e-mail tecnovigilancia@anvisa.gov.br or by telephone (61) 448-1485.

Device

Modular Analyzers of Clinical Chemistry based on Immunological Assays: (1) Model E170, (2) Integr...

Manufacturer

Roche Diagnostics Corp [391899], 9115 Hague Rd, Indianapolis IN 46256 (distribuidor); Hitachi Ltd...
  • Source
    ANVSANVISA