Events

Abbott CELL-DYN Analyzers: (1) Model 3200 CS, (2) Model 3200 SL, list of numbers: (1) 04H59-01, 04H59-03; (2) 04H60-01, 04H60-03; serial number: (1) 29983AH to 29993AH, (2) 60873AF to 60906AF; units manufactured after June 23, 2000 that contains 486 microprocessor chips 의 안전성 경고

Agência Nacional de Vigilância Sanitária (ANVISA)에 따르면, 해당 안전성 경고 는 Brazil 에서 Abbott Laboratories Diagnostic Div 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
    333
  • 날짜
    2001-11-16
  • 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
    ANVISA is interested in following if there has been good collaboration of the manufacturer | your laboratory. Notify any occurrences associated with these products, to ANVISA, Technovigilance Unit, filling out the Health Product Associated Notifications Form available on the Internet http://www.anvisa.gov.br/tecnovigilancia and send directly online or save the file completed and send by e-mail tecnovigilância@anvisa.gov.br, or print it and send it by fax 0xx61-4481257.
  • 원인
    At elevated temperatures, the above analyzers may exhibit a variation in haematological results due to a failure of the 486 microprocessor chip. the manufacturer initiated the removal by telephone on august 30, 2000 and by letter dated september 7, 2000.
  • 조치
    Check your phone receipt on August 30, 2000 and / or the letter dated September 7, 2000 from Abbott Laboratories. Discontinue use of the above product and use another method to report haematological results until an Abbott representative can visit your facility. If your Model 3200 CS or Model 3200 SL CELL-DYN analyzer has been installed, a local Abbott representative must have checked your drive and replaced the defective 486 microprocessor chip with a good 486 microprocessor chip. If you are a new customer of CELL-DYN and your analyzer has not been installed, your local Abbott representative will inspect and replace any defective 486 microprocessor chips during installation in your unit. For more information, please contact your local representative.

Device

Abbott CELL-DYN Analyzers: (1) Model 3200 CS, (2) Model 3200 SL, list of numbers: (1) 04H59-01, 0...

Manufacturer

Abbott Laboratories Diagnostic Div
  • Source
    ANVSANVISA