Events

Product name: VITROS 4600 CHEMICAL SYSTEM / VITROS 5600 INTEGRATED SYSTEM Technical Name: Biochemical Analyzer / Biochemical Analyzer ANVISA Registration Number: 80145901335 Hazard Class: I Affected Model: Vitros 4600 Chemical (Viton 4600 / 5600 (R.Anvisa 80145901205) Serial numbers affected: VITROS® 4600 Chemistry System, Software Version 3.3, Product Code 6802445. VITROS® 5600 Integrated System, Software Version 3.3, Product Code 6802413 and 6802915. 의 안전성 경고

Agência Nacional de Vigilância Sanitária (ANVISA)에 따르면, 해당 안전성 경고 는 Brazil 에서 Johnson & Johnson do Brasil Ind. e Com. de Prod. para Saúde Ltda; Ortho-Clinical Diagnostics, Inc. 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
    2106
  • 날짜
    2016-10-18
  • 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
    • Ensure that previously downloaded V-Docs for Software Version 3.3 are replaced with the correct files when installing the software through the DVD. Correct V-Docs files are available on the software DVD being sent to all clients. Additional instructions and information are located on page three. • Continue to consult the attached Technical Bulletin until the correct V-Docs files for Software Version 3.3 are in the system (s). • Place this notification on the VITROS System or together with the user documentation. • Complete and return the Receipt Confirmation Form. Please enter the J number of the systems on which you installed the software through the DVD.
  • 원인
    This notice provides additional information from a product correction notification that ortho-clinical diagnostics, inc. (ortho) issued in december 2015 with the following sequence of events: • december 2015: ortho issued a notice of correction product (ref. cl2015-201) on the need to clarify the actions of the operator after receiving condition codes u90-382 generated by vitros systems. condition codes u90-382 are associated with wash error codes. • may 2016: ortho issued a follow-up notification (ref. cl2016-072) and technical bulletin with new operator actions recommended when receiving condition codes u90-382. • august 2016: ortho issued a notice (ref. cl2016-093) on the availability of software version 3.3. later, it was identified that software version 3.3 launched via e-connectivity® contained files of the v-docs associated to the previous version of the software (that is, version 3.2).
  • 조치
    Field Action Code 16000153 triggered under the responsibility of Johnson & Johnson of Brazil Ind. And Com. De Prod. for Health Ltda. Company will make correction in the field.

Device

Product name: VITROS 4600 CHEMICAL SYSTEM / VITROS 5600 INTEGRATED SYSTEM Technical Name: Biochem...

Manufacturer

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