Events

Alerte De Sécurité sur Product name: ID-DiaClon Anti-N (MNS2) and ID-DiaClon Anti-M / -N /// Registration number: 80004040126 /// Lots: 50221.73.01 and 50221.73.03 (D-DiaClon Anti- N (MNS2) (REF 007111)) / / Product hazard class: III.

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 DiaMed Latino América S.A.; Diamed 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
    1864
  • Date
    2016-04-15
  • 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
    In specific situations, negative samples may be interpreted as positive. However, as mentioned in "conclusions of the risk assessment" there is no risk to the patient.
  • Cause
    The anti-n component of the products id-diaclon anti-n (mns2) and id-diaclon anti-m / -n, in specific conditions, may present unexpected interference with samples that do not have corresponding antigen (n negative).
  • Action
    Action code: AC 2016/01 /// The field action consists of issuing IMPORTANT FIELD COMMUNICATION /// The company recommends "not validate any positive result that presents a reaction whose force is less than 3 (according to images of the important communiqué field - annex). Negative and positive results with forces between 3+ and 4+ can be validated unconditionally. If the automatic validation function of the equipment is being used, disable the function, especially when the tests - mo45d and pr44n - are performed, because in that situation such interference can be interpreted as positive by the system. This implies that the above tests must be run separately, since it is not possible to disable automatic validation only for these two tests. The test should be repeated for results that are not clearly positive or negative. If the results are not clearly negative, the test should be repeated using an alternative method (id-profile iii). / / LETTER TO THE CLIENT IN ANNEX.

Device

Product name: ID-DiaClon Anti-N (MNS2) and ID-DiaClon Anti-M / -N /// Registration number: 800040...

Manufacturer

DiaMed Latino América S.A.; Diamed GmbH