Events

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 의 안전성 경고

Agência Nacional de Vigilância Sanitária (ANVISA)에 따르면, 해당 안전성 경고 는 Brazil 에서 bioMérieux Brasil Indústria e Comércio de Produtos Laboratoriais Ltda.; bioMérieux S.A. 에 의해 제조된 제품과 관련되어 있습니다.

이것은 무엇인가요?

안전성 경고는 의료기기 제품과 관련된 중요한 정보와 권고사항을 담고 있습니다. 물론 안전성 경고가 배포되었다고 해서 해당 제품이 무조건 안전하지 않은 제품이라는 것은 아닙니다. 보건의료업계 종사자와 의료기기 사용자들에게 배포되는 안전성 경고에는 회수(recall)도 포함될 수 있습니다. 제조사가 안전성 경고를 작성하기도 하지만, 보건당국에서 작성하는 경우도 있습니다.

데이터에 대해 더 자세히 알아보기 여기
  • 사례 유형
    Safety alert
  • 사례 ID
    2007
  • 날짜
    2016-08-10
  • 사례 국가
    Brazil
  • 사례 출처
    ANVISA
  • 사례 출처 URL
    http://www.anvisa.gov.br/sistec/alerta/consultaralerta.asp
  • 비고 / 경고
    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.
  • 데이터 추가 비고
    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.
  • 원인
    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.
  • 조치
    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.