Events

Alerte De Sécurité sur E-test colistin (30 and 100 strips) ANVISA registration number: 10158120623 Hazard class: II Affected model: n / a Serial numbers affected: - Reference number 537300: 100483220 , 1004437930,1004329220,1004190730,1004171220,1003969990,1003767080,1003725600,1003610660,1003532330,1003514810, 1003409250,1003297790,1002849110,1002816570,1002780680,1002594030,1002517610,1002438560,1002336190,1002154530,1001742150,1001496200,1001417080 1001260560.1001158900, 1000941970,1000893880,1000756330 and 1000714690. - Reference 537308: 10044750,1002523000,1002703940,1002795210,1002889130,1002989530,1003456440,1003456440 1003616140,1003767090,1004177660,1004596710,1004752310 and 1002343060

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 bioMérieux Brasil Indústria e Comércio de Produtos Laboratoriais Ltda.; bioMérieux S.A..

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
    2007
  • Date
    2016-08-10
  • 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 company information: 1- Share the information with all laboratory staff. 2- Continue the use of the E-test Colistin CO256 for diagnosis of strains of Enterobacteriaceae, only if done in conjunction with Mueller Hinton E of bioMérieux. 3- If the client does not use Mueller Hinton E from bioMérieux, or if other strains other than Enterobacteriaceae are tested, we recommend the restricted use of the E Colistin CO256 E-test for epidemiological surveys. As this is a test only for use by healthcare professionals, it does not fit recommendations to patients. ### Update of the field action: UPDATED ON 10/25/2017, the company presented the report of completion of the field action proving the sending of the security warning to the client with evidence of science and all actions completed.
  • Cause
    Based on scientific publications (including eucat) on gradient tests and colistin diffusion discs, including e-test (ref .: 537300 and 37308), biomérieux was alerted to a potential underestimation of mic values ​​for enterobacteriaceae and acinetobacter microorganisms . biomérieux began an investigation to confirm the performance of the product and determine the root cause of the problem.
  • Action
    Field Action No. FSCA 3061, triggered under the responsibility of the company bioMérieux SA Risk classification: II Classification of the field action: Sending of guidance letter to the customers who acquired the lots distributed in Brazil. Sample letter attached to this form.

Device

E-test colistin (30 and 100 strips) ANVISA registration number: 10158120623 Hazard class: II Affe...

Manufacturer

bioMérieux Brasil Indústria e Comércio de Produtos Laboratoriais Ltda.; bioMérieux S.A.