Events

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

Selon Agência Nacional de Vigilância Sanitária (ANVISA), ce/cet/cette alerte de sécurité concerne un dispositif en/au/aux/à Brazil qui a été fabriqué par Johnson & Johnson do Brasil Ind. e Com. de Prod. para Saúde Ltda; Thermo Fisher Scientific Oy..

Qu'est-ce que c'est?

Les alertes fournissent des informations importantes et des recommandations concernant les dispositifs médicaux. Le fait qu'une alerte soit émise ne signifie pas nécessairement qu'un dispositif soit dangereux. Les alertes de sécurité, qui sont envoyées tant aux travailleurs du secteur médical qu'aux utilisateurs de ces dispositifs, peuvent inclure des rappels. Elles peuvent être rédigées par des fabricants mais aussi par des autorités en charge de la santé.

En savoir plus sur les données ici
  • Type d'événement
    Safety alert
  • ID de l'événement
    1586
  • Date
    2015-05-14
  • Pays de l'événement
    Brazil
  • Source de l'événement
    ANVISA
  • URL de la source de l'événement
    http://www.anvisa.gov.br/sistec/alerta/consultaralerta.asp
  • Notes / Alertes
    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.
  • Notes supplémentaires dans les données
    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.
  • Cause
    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