Events

ARCHITECT SHBG REAGENT / ARCHITECT SHBG REAGENT Technical Name: GLOBULIN-CONTAINED SEXUAL HORMONE (SHBG) ANVISA Registration Number: 80146501359 Hazard Class: II Affected Model: Not applicable Affected serial numbers: 01916E000, 00316F000, 01816G000, 00916I000 , 07316I000, 00916L000, 01816E000, 00216F000, 01716G000, 00816I000 and 07216I000. 의 안전성 경고

Agência Nacional de Vigilância Sanitária (ANVISA)에 따르면, 해당 안전성 경고 는 Brazil 에서 Abbott Laboratórios do Brasil; Abbott GmbH & Co. KG. 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
    2297
  • 날짜
    2017-05-22
  • 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
    1) Immediately discontinue the use of potassium EDTA-type tubes with the ARCHITECT SHBG assay according to your laboratory procedures. 2) Review this statement with your Medical Officer to ensure that he or she is aware of the problem and to decide whether a review of previously generated results is required using potassium EDTA-type sample tubes. 3) If you have forwarded the product listed above to other laboratories, please inform them of this Product Fix and provide a copy of this notice. 4) Please complete and submit the Customer Response Form. 5) Keep a copy of this statement in your lab files. #### Update of the field action: UPDATED ON 09/27/2017, the company presented the report of completion of the field action, with sending of necessary evidences and corrective actions.
  • 원인
    Abbott has identified that the results of the architect shbg assay generated with the potassium edta-type tube may demonstrate a negative change from the results generated with serum samples. disruption of shbg dimer in edta may result in low shbg measurements by immunoassays *. all currently valid batches of reagent stock are impacted. * fillmore cm, fear tr, hoover rn et al. biomarkers: biochemical indicators of exposure, response, and susceptibility to chemicals. biomarkers 2000; 5 (5): 395-398.
  • 조치
    Field Action Code FA18APR2017 triggered under the responsibility of ABBOTT LABORATORIES DO BRASIL LTDA. Company will make correction in the field.

Device

ARCHITECT SHBG REAGENT / ARCHITECT SHBG REAGENT Technical Name: GLOBULIN-CONTAINED SEXUAL HORMONE...

Manufacturer

Abbott Laboratórios do Brasil; Abbott GmbH & Co. KG.
  • 제조사 모회사 (2017)
    Abbott Laboratories
  • 제조사 의견
    “We are in constant communication with regulatory agencies and competent authorities worldwide which allows us to implement global recalls or in-country communication quickly and effectively,” Abbott, which now owns St. Jude Medical told ICIJ in a statement. In addition to sending global notices to physicians worldwide, we also make sure that product advisories are available online and classification of product recalls and product advisories are determined by global regulatory bodies which can impact the timing in any given country. MD companies follow varying regulations in different countries. In come countries software is not regulated so a recall in one country related to software would not be classified as a recall or field action in another. In addition, review cycles within the regulatory process can be different in each country which can impact communication and recall timing.
  • Source
    ANVSANVISA