Events

Safety Alert for CHEMICAL SYSTEM VITROS 5,1 FUSION - Codes 6801375/6801890/6801890, Record no. 80145900827, lots: See Annex 1 - Distribution list.

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
    1675
  • Date
    2015-08-27
  • 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
    The company informs that if this anomaly occurs, the VITROS® 5.1 FS System can process samples using the factory default report units that exist in the ADD, instead of the parameters modified by the user (ie SI vs. Conventional units) . The company also informs that it has identified that the root cause of this anomaly is an error in the software code. The resolution is currently under development and will be available in the future version of the software.
  • Reason
    The company received 2 customer complaints about events that occurred during the installation of an add. the following two situations have been reported: 1. when the customer installed the add compatible with the new vitros® chemistry products hba1c reagent kit, the vitros® 5.1 fs system reported the following 2 condition codes (ua7-239 and syd-024 ): the investigation detected that the condition codes occurred because the abbreviated test name of the new vitros® test had the same abbreviated test name as the user defined assay currently in use on its vitros® 5.1 system fs. as a result, the destination of user defined assay has been deleted from the system. 2. when a customer installed the add, the system did not respond (freeze / screen lock), causing the vitros® 5.1 fs system to restart; the system reported a condition code (uz0-047) after the system restarts. - for the 2 software coding error situations, all the default settings were restored from the add, instead of keeping the parameters modified by the user (configured), and the operator was not alerted by the system.
  • Action
    The company advises that: • Before installing an ADD compatible with a new test, make sure that the new test does not have the same name as another UDA currently on your system. If the names are the same, you will need to: 1. Rename the UDA with a name that is different from the VITROS® short test name 2. Install the ADD. More information in Annex 2 - Communication to customers

Device

CHEMICAL SYSTEM VITROS 5,1 FUSION - Codes 6801375/6801890/6801890, Record no. 80145900827, lots: ...

Manufacturer

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