Events

Safety Alert for CHEMICAL SYSTEM VITROS 4600 (Reg 80145900827) / CHEMICAL SYSTEM VITROS 5,1 FUSION (Reg 80145900827). Hazard Class: I. Products Affected: All VITROS® 4600 Diagnostic Systems with softaware version 3.2 and earlier and all VITROS® 5.1 Fusion Diagnostic Systems with software version 2.8 and earlier. List of affected SNs distributed in Brazil are in Annex I of this notification.

According to Agência Nacional de Vigilância Sanitária (ANVISA), this safety alert involved a device in Brazil that was produced by Johnson & Johnson do Brasil Ind. e Com. de Prod. para Saúde Ltda.; 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
    1772
  • Date
    2015-12-18
  • 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
    Considering the reduced likelihood that the anomaly will occur (<1 in 14 million), it is possible for the VITROS® 4600 and 5.1 FS Systems to process samples outside the appropriate temperature range where results will not be indicated with a result code of "IT" (incubator temperature).
  • Reason
    Ortho clinical diagnostics (ortho) has recently identified that under very specific conditions the temperature in the microwell subsystem (included in other vitros® systems) may potentially be out of range and the system does not properly alert the operator. although it does not include a microwell subsystem, the vitros® 4600 and 5.1 fs systems use the same software as the other vitros® systems. ortho has estimated that there is a 1 in 14 million lower incidence possibility that this anomaly might occur in the microslide or microtip subsystems included in the vitros® 5,1 fs systems, based on e-connectivity data.
  • Action
    Recommendations to users and patients: Because of the reduced likelihood of this anomaly occurring, Ortho is not requiring the temperature of its system to be monitored. However, the customer may choose to check that his system is within the appropriate temperature range. Field Action Code: 15000167

Device

CHEMICAL SYSTEM VITROS 4600 (Reg 80145900827) / CHEMICAL SYSTEM VITROS 5,1 FUSION (Reg 8014590082...

Manufacturer

Johnson & Johnson do Brasil Ind. e Com. de Prod. para Saúde Ltda.; ORTHO CLINICAL DIAGNOSTICS, INC