Events

Alerte De Sécurité sur SEROLATEX PRODUCTS - CAT. 56 E 56K - LOTS 0018, 0019 AND 0020. PRODUCTS REUMALATEX PCR - CAT 54 AND 54K

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 LABTEST DIAGNOSTICA.

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
    38
  • Date
    2001-07-24
  • 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
    PROVIDES THAT THE PRODUCT HAS BEEN COLLECTED FROM THE MARKET SEROLATEX CATALOGOS 56 AND 56K, LOTS 0018, 0019 AND 0020, FOR THE PRESENTATION OF TECHNICAL PROBLEMS, EVEN IF THE PRODUCT WILL HAVE ITS MARKETING AND PRODUCTION DISCONTINUED UNTIL THE END OF DECEMBER 2001, THIS TIME TO TRY SOLVING THE PROBLEM. AND AS A PREVENTIVE MEASURE OPTION TO DISCONTINUE FOR THE SAME PERIOD, THE PRODUCTION AND MARKETING OF THE REUMALATEX PRODUCT CATÁLOGOS 54 AND 54K FOR USING A TECHNOLOGY SIMILAR TO SEROLATEX PCR.
  • Cause
    Technical problems occurring with the supplier's raw material.
  • Action
    LABTEST DIAGNOSTIC REPORTS THAT THE PRODUCT SEROLATEX CATALOGS 56 AND 56K, LOTS 0018, 0019 AND 0020, FOR THE PRESENTATION OF TECHNICAL PROBLEMS, HAS BEEN OBTAINED FROM THE MARKET, IT FURTHER INFORMES THAT THE PRODUCT WILL HAVE THE MARKETING AND PRODUCTION DISCONTINUED UNTIL THE END OF DECEMBER 2001, PERIOD THIS TO TRY TO SOLVE THE PROBLEM. AND AS A PREVENTIVE MEASURE OPTION TO DISCONTINUE FOR THE SAME PERIOD, THE PRODUCTION AND MARKETING OF THE REUMALATEX PRODUCT CATÁLOGOS 54 AND 54K FOR USING A TECHNOLOGY SIMILAR TO SEROLATEX PCR.

Device

SEROLATEX PRODUCTS - CAT. 56 E 56K - LOTS 0018, 0019 AND 0020. PRODUCTS REUMALATEX PCR - CAT 54 A...

Manufacturer

LABTEST DIAGNOSTICA
  • Source
    ANVSANVISA