Events

Alerte De Sécurité sur CHOLINESTERASE FS (COLINESTERASE FS) Technical Name: COLINESTERASE Registration Number ANVISA: 10350840138 Hazard Class: II Affected Model: R1: 5 x 20 mL / R2: 1 x 25 mL Serial Numbers Affected: 60109928

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 BIOSYS LTDA; DiaSys Diagnostic Systems GmbH.

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
    2130
  • Date
    2016-12-19
  • 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
    Customers / users who have purchased the batch related to this notification are directed to segregate all units of the product as nonconforming product and returned to our care, for later replacement by another suitable batch. It is further recommended that the results eventually measured with the quoted batch be checked using another batch number. #### Update of the field action: UPDATED ON 10/16/2017, the company presented the report of completion of the field action, with sending evidence of the collection and destruction of the affected products.
  • Cause
    Biosys ltda., the record holder of the referenced product, received a communication from the international manufacturer of the same, diasys diagnostic systems gmbh, stating that of the product colinesterase fs lot 60109928 had to be withdrawn from the market due to a failure in the packaging process of the product. reagent r2 and the units already marketed should be collected. due to failure of the r2 container both patient and control samples will show false low results or even an error report in the results to and process the enasio in automatic machines. biosys informs that it has not received a customer complaint related to the product in question.
  • Action
    Field Action Code 4130 triggered under the responsibility of the company BIOSYS LTDA. Company will collect for further destruction.

Device

CHOLINESTERASE FS (COLINESTERASE FS) Technical Name: COLINESTERASE Registration Number ANVISA: 10...

Manufacturer

BIOSYS LTDA; DiaSys Diagnostic Systems GmbH
  • Source
    ANVSANVISA