Events

Alerte De Sécurité sur ADVANTAGE II, TESTS WITH TAPES FOR GLUCOSE. ALL LOTS BEGINNING WITH NUMBER LESS THAN 445.

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 ROCHE DIAGNÓSTICOS CORP. SUB F HOFFMANN-LA ROCHE LTDA.

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
    79
  • Date
    2001-05-04
  • 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
    BRAZIL 06 / JULY / 2001 - COMFORT STRIP VERSION (BRAZIL) UNTIL THIS DATE NO REGARDLED OCCURRENCE VERSION CONFORT TURBO WAS NOT AND IS NOT STILL MARKETED IN BRAZIL. IT FURTHER INFORMES THAT ROCHE DIAGNOSTICS IS DEVELOPING A NEW VERSION OF THE TURBO CONFORT STRIP THAT WILL NOT PRESENT THE PROBLEM OF CONFLICT WITH THE MONITOR ADVANTAGE COMPLETE. THIS UPDATED VERSION OF STRIPS THAT WILL NOT PRESENT CONFLICT WITH THE COMPLETE ADVANTAGE WILL HAVE LOT NUMBERS STARTING WITH 445 XXX.
  • Cause
    The complete advantage glycometer, when used with the advantage ii ribbons, does not operate the alarm to notify the operator if a second blood drop must be added to the ribbon when the first is insufficient. the manufacturer began removal day, march 21, 2001.
  • Action
    MAKE SURE THAT YOU HAVE RECEIVED THE ROCHE REMOVAL LETTER DIAGNOSTICS ON MARCH 21, 2001. IDENTIFY AND DISCONTINUE THE USE OF ALL THOSE AFFECTED PRODUCTS THAT ARE IN YOUR INVENTORY. FOR FURTHER INFORMATION CONTACT YOUR DISTRIBUTOR OR MANUFACTURER ON YOUR PHONE (00XX-1-317-845-2000).

Device

ADVANTAGE II, TESTS WITH TAPES FOR GLUCOSE. ALL LOTS BEGINNING WITH NUMBER LESS THAN 445.

Manufacturer

ROCHE DIAGNÓSTICOS CORP. SUB F HOFFMANN-LA ROCHE LTDA
  • Source
    ANVSANVISA