Events

Alerte De Sécurité sur Name of reagent: Red cell Reag family for Immunohematology R4 - IH Biovue - Other items in Annex 1 Technical name: Reag for immunohematology - Red cell reagent / enzyme-treated red cell number ANVISA registration number: 80145901444 Hazard class: : Surgiscreen -Conj of 3 vials with 3mL each of cel for detection of unexpected antibodies Serial numbers affected: 3SS214Z; 3SS216Z; 3SS222Z; 3SS225Z; 3SS231Z; 3SS238Z; 3SS241Z; 8EA329; 8RA330; 8RA331; 8SS282; 8SS284; 8SS285; 8SS286; 8SS271; 8SS272; 8SS273; 8SS274; 8SS275; 8SS276; 8SS277; 8SS278; 8SS279; 8SS280; 8SS281; 8RC306; 8RC307; 8RC308; 8S893; 8S894; 8S896; 8ª511; 8ª512; 8ª222; 8ª523; 8,548; 8ª534.

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; Ortho-Clinical Diagnostics Inc..

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
    2114
  • Date
    2016-12-02
  • 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
    • Visually inspect all products before use according to the Instructions for Use. Do not use red cell products if marked haemolysis or evidence of contamination is observed. • Contact the Ortho Care ™ Technical Solutions Center to report a product in which marked haemolysis has been observed so that the product can be replaced or credited. • Complete and return the Receipt Confirmation form.
  • Cause
    Ortho clinical diagnostics received a large number of customer complaints and confirmed the intermittent presence of marked hemolysis in ortho reagent red blood cell (rrbc) products, as well as quality control products containing red blood cells. ortho conducted extensive research and the root cause for marked haemolysis was identified as microbial contamination.
  • Action
    Field Action Code 16000162 triggered under the responsibility of Johnson & Johnson do Brasil Ind. And Com. De Prod. for Health Ltda. Company will make correction in the field.

Device

Name of reagent: Red cell Reag family for Immunohematology R4 - IH Biovue - Other items in Annex ...

Manufacturer

Johnson & Johnson do Brasil Ind. e Com. de Prod. para Saúde Ltda; Ortho-Clinical Diagnostics Inc.