Events

Safety Alert for Vitros Chemistry Systems: (1) Model 950, (2) Model 950AT. Series Nos .: (1) below 09501559, (2) below 09600129

According to Agência Nacional de Vigilância Sanitária (ANVISA), this safety alert involved a device in Brazil that was produced by Ortho-Clinical 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
    223
  • Date
    2000-12-15
  • 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
    In the chemical systems described, an atypical pattern occurred in the relation between the millivolt slide used to calculate a predicted concentration and the reading of the millivolt slide used to evaluate the slide impedance. the manufacturer initiated a correction by mail dated february 28, 2000.
  • Action
    Make sure you have received the correspondence sent on February 28, 2000, by Ortho-Clinical Diagnostics. Confirm that software version 2.04 or newer is installed on the systems described. Ortho-Clinical Diagnostics states that removal in the United States is now complete. No additional action is required by US service providers. International removal is in progress. Contact your local Ortho-Clinical Diagnostics representative or directly to the United States by mail at the address listed for more information on removal procedures.

Device

Vitros Chemistry Systems: (1) Model 950, (2) Model 950AT. Series Nos .: (1) below 09501559, (2) b...

Manufacturer

Ortho-Clinical Diagnostics Inc