Events

Alerte De Sécurité sur Name of products: Immunodiagnostic reagent Vitros for Syphilis TPA, ANVISA Registry 80145901397. Classification IV. 7,400 affected units were imported by Brazil, of which 4,300 were distributed in the Brazilian market. Only one product code was affected (6842803), and the lots and distribution site 0514 (300 units in Belo Horizonte MG, 100 units in Tangará da Serra-MT, 2,900 units in Curitiba-PR, 100 units Campos dos Goytacazes-RJ and 100 units in São Gonçalo-RJ), 0515, 0520 (700 units in Campos dos Goytacazes-RJ and 100 units in Piracicaba), 0531

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; Ortho Clinical Diagnostics.

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
    1893
  • Date
    2016-05-09
  • 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
  • Cause
    Potential for inability to obtain a valid calibration when using vitros reagent kits for syphilis tpa, lots 0514, 0515, 0520 and 0531. ortho's investigation has confirmed that these batches of the vitros syphilis tpa reagent kit have met the warranty release specifications of quality. however, upon release, these batches exhibited a reduction in the reaction signal to the level of calibrator 1. initial tests indicate that the unexpected signal decrease is related to a specific batch of feedstock used in the manufacture of the product. as a result of this problem, you should discontinue use of the product and discard the affected lots.
  • Action
    Action code 16000062. Discontinue use and discard any remaining inventory of VITROS Reagent Kits for Syphilis TPA, Lots 0514, 0515, 0520 and 0531 and corresponding calibrators. (Manufacturer's Note: If the laboratory can successfully calibrate affected batches, and QA results are acceptable, the laboratory may continue to use the affected batches until it receives its replacement request.) Forward this notification if Kits have been provided of VITROS Reagent for Syphilis TPA, Lots 0514, 0515, 0520 and 0531 for other people outside your facility. Place this notification next to each VITROS® System that processes the VITROS Reagent Kits for Syphilis TPA.

Device

Name of products: Immunodiagnostic reagent Vitros for Syphilis TPA, ANVISA Registry 80145901397. ...

Manufacturer

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