Events

IMX T 4 FREE REAGENTS, Reg. No. 10055310036, list no. 2222-20 lot no. 01550Q100 and FREE T4 CONTROLS, Reg. No. 10055311050, list no. 9C03-10, lot no. 95881Q100 의 안전성 경고

Agência Nacional de Vigilância Sanitária (ANVISA)에 따르면, 해당 안전성 경고 는 Brazil 에서 ABBOTT LABORATÓRIOS DO BRASIL LTDA 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
    738
  • 날짜
    2003-06-25
  • 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
    Check if you received communication from 16.07.2003 of ABBOTT LABORATORIES DO BRASIL LTDA, if you have not received contact ABBOTT LABORATORIES DO BRASIL LTDA by telephone 11 5367000 or your local representative. ----- BRAZIL 10/09/2003 - Date of Beginning of the Collection: 06/16/2003 ---- /////// ---- Completion Date of the Collection 21/08/2003.
  • 원인
    The mid-level control of free t4 controls, lot # 95881q100, showed a high value for the range mentioned in the instructions for use of the product during investigation of an occurrence. the free t4 controls, lot # 95881q101 (lots not received in brazil) is a sublot of 95881q100, from which complaints about the same occurrence of out of range controls were received. the imx mode 1 calibrator, lot # 96726q100 is the batch of calibrator found on the imx t4 free reagents, batches # 01550q100. this batch of mode 1 calibrator was manufactured with the same components as the control batches mentioned. this lot has been shown to produce an underestimation of the free t4 level in patient samples of up to 29%.
  • 조치
    Check if you received communication from 16.07.2003 of ABBOTT LABORATORIES DO BRASIL LTDA, if you have not received contact ABBOTT LABORATORIES DO BRASIL LTDA, by telephone 11 5367000 or your local representative.

Device

IMX T 4 FREE REAGENTS, Reg. No. 10055310036, list no. 2222-20 lot no. 01550Q100 and FREE T4 CONTR...

Manufacturer

ABBOTT LABORATÓRIOS DO BRASIL LTDA
  • Source
    ANVSANVISA