Events

Safety Alert for VITROS 5.1 FUSION Chemical System, Registration No. 80145900827 and VITROS 4600 and 5600 Chemical System, Registration No. 80145901335, lots / Serial No .: 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
    1587
  • Date
    2015-05-14
  • 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 for urine samples from patients who require pre-treatment, place each of the pre-treated sample types in a separate container. Manually program the individual samples. NOTE: A LIS download can be used to program urine samples only if tests that require sample pretreatment and tests that do not require pretreatment are not included in the same sample program. Place this notification on each VITROS® 4600, 5600, and 5.1FS System of your installation or together with the user documentation. Talk to your Lab Medical Director about any questions regarding previously reported results to determine the appropriate course of action.
  • Reason
    The company reported that ortho-clinical diagnostics, inc. (ocd) has confirmed cases for vitros® 5,1 fs (software version 2.8 and previous) and vitros® 4600 and 5600 systems (software version 3.2 and previous). that the vitros® system allowed urine specimens for testing requiring acidification pretreatment to be dosed from the same sample vessel as non-pretreatment tests when samples were programmed.
  • Action
    The company informs that if this anomaly occurs, it is possible that the VITROS® 4600, 5600 and 5.1 FS Systems process urine samples without correct pretreatment, leading to potential outcomes of patients with bias. See attached table of communication with examples of biased results obtained during the research.

Device

VITROS 5.1 FUSION Chemical System, Registration No. 80145900827 and VITROS 4600 and 5600 Chemical...

Manufacturer

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