Events

Alerte De Sécurité sur VITROS IMMUNODIAGNOSIS CALIBRATOR FOR CA 125 II, Registration nº 10132590524, lots: See Annex 1 - Distribution List.

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 Johnson & Johnson do Brasil Ind. e Com. de Prod. para Saúde 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
    1314
  • Date
    2013-10-18
  • 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
    The company informs that the tests have confirmed that Batches 1240 and 1250 continued to perform within the product specifications and that it is acceptable to continue using the remaining inventory by the expiration date as long as the quality control results are within acceptable limits . Note: Lot 1240 expires on October 16, 2013; Lot 1250 expires on November 15, 2013.
  • Cause
    The company holding the record reports an investigation has detected that the signal for all affected batches levels of the vitros ca 125 ii ™ calibrators increased during the shelf life of the product, resulting in negative bias in patient outcomes and control of quality. the internal tests confirmed that this is an isolated problem for lots 1220, 1230, 1240 and 1250. the observed maximum bias was -15%, since lot 1240 was near the expiration of its expiration date compared to lot 1270. as a result of negative bias and normal batch-to-batch variation, a significantly positive deviation in patient outcomes and quality control can be observed when using lot 1260 or above when compared to affected batches.
  • Action
    The company advises clients to consider the need to review the results of patients for whom they have used affected batches. If you suspect that the previously reported result may have been affected, please provide this information to your Laboratory Medical Director and the requesting physician or health professional so that appropriate actions can be taken for patients with ovarian epithelial cancer whose response to therapy is being monitored with the VITROS CA 125 II ™ test. Report the occurrence to our Technical Services representatives to the Customer. - Complete and return the attached Confirmation of Receipt form. - Forward the information in this notification if you have distributed this product outside your facility. See letter to the Client (Annex III).

Device

VITROS IMMUNODIAGNOSIS CALIBRATOR FOR CA 125 II, Registration nº 10132590524, lots: See Annex 1 -...

Manufacturer

Johnson & Johnson do Brasil Ind. e Com. de Prod. para Saúde Ltda