Events

Alerte De Sécurité sur VITROS IMMUNODIAGNOSIS CONTROL FOR ONCOLOGY - LOT 0220 - Code 1935543 - Registered in Anvisa under the number 10132590516.

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 Indústria e Comércio de Produtos para a 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
    991
  • Date
    2009-10-07
  • 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 ratifies that the investigation indicates that this problem affects only the performance of the quality control samples, and no bias was observed in the results of patient or proficiency. VITROS Oncology Controls, batches 0220 and 240, perform normally when used for the measurement of all other VITROS immunostaining products listed, as specified in the Instructions for Use of VITROS Controls for Oncology. According to the company's traceability system, only lot 0220 was imported into the Brazilian market and customers have already been notified by letter. It will not be necessary to collect the product. Anvisa is following this action.
  • Cause
    The manufacturer has identified that batches 0220 and 0240 - code 1935543 of the vitros immunodiagnostic control for oncology can generate results outside the upper limit of 2sd for all control levels, when used with lot 1000 and later of the vitros immunodiagnostic reagent kits for ca 125 ii (code 6800038). as a result, the vitros controls for oncology, lots 0220 and 0240 will not have assigned values ​​for the vitros reagent kits for ca 125 ii, lots 1000 and later.
  • Action
    Recommended actions for users of the product are: (1) Use of an alternate batch of VITROS Controls for Oncology to verify and monitor the performance of Batches 1000 and later of VITROS Immunodiagnostic Reagent Kits for CA 125 II, if available; (2) Establish appropriate ranges of VITROS Control for Oncology for VITROS Reagent Kits for CA 125 II, 1000 and later batches. If the laboratory has already established its own control bands, it is acceptable to continue to use these bands. An alternative commercial control should be used until a VITROS Control for Oncology batch is available with the values ​​assigned to the VITROS Reagent Kits for CA 125 II.

Device

VITROS IMMUNODIAGNOSIS CONTROL FOR ONCOLOGY - LOT 0220 - Code 1935543 - Registered in Anvisa unde...

Manufacturer

Johnson & Johnson do Brasil Indústria e Comércio de Produtos para a Saúde Ltda.