Events

Safety Alert for EnGen ™ Laboratory Automation System - TCA, Registration no. 80145909053, lots / series: J3J4B45J.

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; Thermo Fisher Scientific Oy..

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
    1586
  • 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 reports that OCD internal tests have confirmed cases in which the VITROS® 5,1 FS, 4600 or 5600 Systems allowed the analysis of multiple tests using a single urine sample, regardless of the pretreatment requirements of each selected test, causing potentially outcomes of patients with bias.
  • Reason
    The company that owns the registry informs that urine samples for use with vitros® ca, mg and phos slides require acidification (pre-treatment). the engen ™ system software currently does not route these samples to the manual high priority exit site for pretreatment as indicated. in addition, the engen ™ system software currently allows for the provision of invalid test combinations, which include urine samples with different pre-treatment requirements. depending on the test, urine specimens need to be acidified, alkalized, extracted or untreated prior to being processed on vitros® systems.
  • Action
    The company directs that the service does not request VITROS® Ca, Mg and PHOS Slide tests using urine samples with no other tests. Do not place urine samples for VITROS® Ca, Mg and PHOS Slide tests on the rail for sorting or routing. Place the pre-treated urine samples for these tests directly into the analyzer. Talk to your Lab Medical Director about any questions regarding previously reported results to determine the appropriate course of action.

Device

EnGen ™ Laboratory Automation System - TCA, Registration no. 80145909053, lots / series: J3J4B45J.

Manufacturer

Johnson & Johnson do Brasil Ind. e Com. de Prod. para Saúde Ltda; Thermo Fisher Scientific Oy.
  • Source
    ANVSANVISA