Events

Trade name: CELL-DYN RUBY Technical name: HEMATOLOGICAL ANALYZER ANVISA registration number: 80146501507 Hazard class: II Affected model: Not applicable 의 안전성 경고

Agência Nacional de Vigilância Sanitária (ANVISA)에 따르면, 해당 안전성 경고 는 Brazil 에서 Abbott Laboratórios do Brasil; ABBOTT LABORATORIES 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
    2229
  • 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
    1. Your Abbott service team will contact you to replace the PCBA Pump Relay Plate on the impacted equipment (s) at no cost. 2. Make sure you have a back-up device or alternate method to generate hematology results if the equipment becomes inoperative. 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. Keep this statement in your lab files.
  • 원인
    Abbott hematology has learned that the cell-dyn ruby equipment in its laboratory has a printed circuit board (pcba) assembly that may fail prematurely and result in loss of vacuum / pressure. the pcba pump relay board failure will result in system started messages (sims), including but not limited to the following, and will no longer function: 0840 vacuum accumulator # 1 wet, 1093 mix head failed to complete downward rotation, 1095 mix head not top position, 1096 mix head stuck at top position, 0643 wbc lyse empty * [empty wbc lysis reagent *], 0645 dil / sheath empty *. for messages 0643 and 0645, make sure that the reagent is not empty. if the error message is related to this problem, the machine will stop and you will need to replace the pcba to continue.
  • 조치
    Field Action Code FA13FEB2017 Revision 01 released under the responsibility of the company Abbott Laboratórios do Brasil LTDA. Company will make correction in the field.

Device

Trade name: CELL-DYN RUBY Technical name: HEMATOLOGICAL ANALYZER ANVISA registration number: 8014...

Manufacturer

Abbott Laboratórios do Brasil; ABBOTT LABORATORIES
  • 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