Events

I-STAT KAOLIN ACT CARTRIDGE Technical Name: ACTIVATED COAGULATION TIME ANVISA Registration Number: 80146501500 Hazard Class: III Affected Model: Not applicable Serial Numbers Affected: Customers using software version JAMS142E. 의 안전성 경고

Agência Nacional de Vigilância Sanitária (ANVISA)에 따르면, 해당 안전성 경고 는 Brazil 에서 Abbott Laboratórios do Brasil; Abbott Point of Care 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
    2228
  • 날짜
    2017-03-17
  • 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
    Our records show that your installation is testing the i-STAT Celite ACT or Kaolin ACT cartridges. APOC recommends upgrading all i-STAT analyzers running the Celite ACT or Kaolin ACT test with the JAMS142G software version. This notice only affects the operation of Celite ACT or Kaolin ACT cartridges cartridges. There is no impact on other analytes. Follow the instructions included in this communication for installing the software from the included software disc or the Abbott Point of Care website. Https://www.pointofcare.abbott/us/en/offerings/support/software-license-keys/istat-system-software-update. Fill out and return the customer's response letter to acknowledge receipt of this communication and installation of the software. If you have forwarded the cartridges to another facility, provide a copy of this notice.
  • 원인
    Abbott point of care inc. (apoc) has determined that celite act and kaolin act cartridges can produce falsely low results when very high samples of coagulation time are tested. patient samples with a coagulation time measured> 853 seconds for celite and> 1134 seconds for kaolin may show results of approximately 100 to 200 seconds while using the jams142e software version. the typical therapeutic range of the i-stat act assay is 200 to 600 seconds.
  • 조치
    Field Action Code APOC2017-001 triggered under the responsibility of the company Abbott Laboratórios do Brasil LTDA. Company will make correction in the field.

Device

I-STAT KAOLIN ACT CARTRIDGE Technical Name: ACTIVATED COAGULATION TIME ANVISA Registration Number...

Manufacturer

Abbott Laboratórios do Brasil; Abbott Point of Care Inc.
  • 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