Events

Alerte De Sécurité sur Syringes Technical Name: TREPONEMA PALLIDUM ANVISA Registration Number: 10310030079 Hazard Class: IV Affected Model: COD: 15060-I / 150100-I Serial numbers affected: 16H223 / 16H224P / 16H224PB / 16J166 / 16J166B / 16J167P / 16J167PB

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 WAMA PRODUTOS PARA LABORATÓRIOS LTDA.; Wama Produtos para Laboratório 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
    2125
  • Date
    2016-11-21
  • 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
    Action: We ask customers / distributors to check in their inventory the aforementioned lots. Please segregate material for WAMA to perform immediate replacement. Also inform all the direct customers (laboratories) who have bought that we will exchange their stocks. Batches made from this date will be accompanied with greater sampling to monitor the effectiveness of the actions taken to regularize the test (AC 20161125). #### UPDATED ON 08/29/2017, the company submitted completion report of the field action proving the accomplishment of correction as planned.
  • Cause
    After notifications from a customer, we verified that the product mentioned above presented in the reactive area of ​​some blades of the kit, not suitable fluorescence. this situation can create doubt in the operator and cause false results.
  • Action
    Field Action Code 001/16 triggered under the responsibility of the company WAMA PRODUCTOS PARA LABORATÓRIOS LTDA. Company will make collection for later return to the manufacturer.

Device

Syringes Technical Name: TREPONEMA PALLIDUM ANVISA Registration Number: 10310030079 Hazard Class:...

Manufacturer

WAMA PRODUTOS PARA LABORATÓRIOS LTDA.; Wama Produtos para Laboratório Ltda.