Events

ACID LACTIC Technical Name: Lactic Acid ANVISA Registration Number: 80146501641 Hazard Class: II Affected Model: Not applicable Serial Numbers Affected: 31497UN14; 09353UN15; 45216UN15; 14596UN15; 37055UN15 and 14782UN16 의 안전성 경고

Agência Nacional de Vigilância Sanitária (ANVISA)에 따르면, 해당 안전성 경고 는 Brazil 에서 Abbott Laboratórios do Brasil; Abbott Laboratories Diagnostics Division. 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
    2161
  • 날짜
    2016-11-11
  • 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
    Please forward this notice to your Medical Director. Taking into account the above information, you may continue to use the ARCHITECT Lactic Acid reagent (LN 9D89-21). Complete and return the attached Customer Response Form. 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 to the laboratory in question. Keep this statement in your lab files.
  • 원인
    Abbott identified negative interference of n-acetylcysteine ​​(nac) with the architect lactic acid reagent (ln 9d89-21). the table in the customer's release and annex describes the levels of interference observed at nac concentrations of 80 mg / l (0.49 mmol / l) and 800 mg / l (4.9 mmol / l).
  • 조치
    Field Action Code FA10OCT2016 triggered under the responsibility of ABBOTT LABORATORIES DO BRASIL LTDA. Company will make correction in the field.

Device

ACID LACTIC Technical Name: Lactic Acid ANVISA Registration Number: 80146501641 Hazard Class: II ...

Manufacturer

Abbott Laboratórios do Brasil; Abbott Laboratories Diagnostics Division.
  • 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