Events

Alerte De Sécurité sur Dako complementary reagents, for the following products: 1. Envision FLEX mini-kit, High pH (Link), Registration: 80640680042, lot 20021362 //// 2. Envision FLEX, Hig pH (link), K8023 registration 80640680042, lot 20020777; 20019097; 20021381 //// 3. EnVision FLEX min-kit, High pH (Autostainer / Autostainer Plus), K8010, registration 80640680034, lot 20020792; 20021384. //// 4. EnVision FLEX + Mouse, High pH (link); K8002; registration 80640680042, lot 20019113; 20020772. //// 5. EnVision Flex + Mouse, mini-kit, High pH (Autostainer / AUtostainer Plus), K8012, registration 80640680034. All risk class I.

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 Olympus Optical do Brasil Ltda.; Olympus Medical Systems Corporation..

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
    1731
  • Date
    2015-10-31
  • 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
    According to the company, nonspecific staining can be confused with specific reaction and lead to false positive result. There was no evidence of risk to patients. It is highly unlikely that a diagnostic error occurred if: a suitable negative control tissue had been included in the auxiliary test and not as the sole basis for the diagnosis or treatment regimen.
  • Cause
    A defect was identified in the buffer composing the formulation of one of the kit components, in particular, the polymer / hrp. specific non-specific or specific staining was observed when this reagent was used with four antibodies: epstein-barr virus, mum-1 protein, wilm's tumor (wt-1), smooth muscle actin. there is a possibility that nonspecific staining may be confused by a specific reaction, leading to a false positive result.
  • Action
    The company that holds the record will destroy the target products of the field action. It recommended that cases submitted to affected lots be reassessed. Action code: CAPA00544

Device

Dako complementary reagents, for the following products: 1. Envision FLEX mini-kit, High pH (Link...

Manufacturer

Olympus Optical do Brasil Ltda.; Olympus Medical Systems Corporation.