Events

Safety Alert for CHEMICAL SYSTEM VITROS 5,1 FUSION, Registration 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
    1573
  • Date
    2015-05-04
  • 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, it is possible that the VITROS® 5,1 FS System processes samples with a cartridge other than the intended cartridge, leading to potential erroneous patient results.
  • Reason
    Ortho-clinical diagnostics, inc. (ocd) has confirmed two cases in which the vitros® microslide cartridge has not been correctly identified. both cases occurred when an operator accessed slide supply 1 (ss1) before the green indicator light came on and then continued loading a dry reaction cartridge into slide supply 2. in both cases, the cartridge loaded in slide supply 2 was not correctly identified.
  • Action
    The solution to this anomaly will appear in the next version of software currently under development. We'll issue a follow-up notification as soon as the software is available. In the meantime, if an operator inadvertently accesses a Slide Supply loading port before the green indicator light comes on and the system generates a TAS-70E or TAS-20E condition code (SLIDE SUPPLY 1 is OPEN or the SLIDE PORT SUPPLY 2 is OPEN), the operator must open and close the two Slide Supply ports (Slide Supply No. 1 and 2), remove or load cartridges, and initialize the system. This will cause the system software to scan all slots on the two Slide Supplies to correctly identify the contents.

Device

CHEMICAL SYSTEM VITROS 5,1 FUSION, Registration no. 80145900827, lots: See Annex 1 - Distribution...

Manufacturer

Johnson & Johnson do Brasil Ind. e Com. de Prod. para Saúde Ltda; Ortho-Clinical Diagnostics, Inc.