Events

Product trade name: ARCHITECT ANTI-HBc II CONTROLS / ARCHITECT ANTI-HBc II CONTROLS /// Registration number: 80146501604 /// Affected batch: 54570LI00 / / / Product hazard class: IV. 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
    1878
  • 날짜
    2016-04-20
  • 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
    Risk assessment was not required as there is no impact on patient outcomes or product performance as a consequence of this problem. / / There is no impact on patient outcomes or product performance as a consequence of this problem./// We ask apologies for any inconvenience caused. Abbott is committed to providing the highest quality diagnostic products and support services to meet the needs of its laboratory, suppliers and patients.
  • 원인
    The company clarifies that "during the labeling process of the architect anti-hbc ii control, list number (ln) 8l44-10, lot 54570li00, an incorrect use statement (ifu) and country-specific label were inserted / applied to a limited number of kits (63). the incorrect ifu / country-specific label was from the architect anti-hbc ii calibrator, ln 8l44-01. ".
  • 조치
    Risk classification: IV /// Field action classification: product recall for further destruction /// Field action code: FA14APR2016 /// Recommendations to users and patients: discontinue use of the ARCHITECT Anti-HBc Control kits II of lot 54570LI00; if you are currently using or have the aforementioned batch in stock, immediately contact Customer Support; the remaining stock of the batch will be collected and destroyed by an Abbott representative /// If you have shipped the product specified above to other laboratories, please inform them about this Product Recall and provide them with a copy of this release. Keep this notice in your lab records.

Device

Product trade name: ARCHITECT ANTI-HBc II CONTROLS / ARCHITECT ANTI-HBc II CONTROLS /// Registrat...

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