Events

PROLATIN KIT OF AxSYM and IMx - PROLACTIN CALIBRATES Reg. No. 10055311055 n ° list 9C07-01 - Lots 75255Q100, 78013Q100, 79026Q100 and 80697Q100 - PROLACTIN CONTROLS Reg. No. 10055311058 n ° list 9c07-10, lot 77575Q100, 78753Q100, 80284Q100 and 81124Q100 - AxSYM PROLACTIN MASTER CALIBRATES Reg. No. 10055311055, list no. 7A62-32, lot 7556Q100, 78020Q100, 79027Q100, 80584Q100 and 83668Q100 - IMx PROLACTIN REAGENTS Reg. No. 10055310228, list no. 2244-22, lot no 78752Q100 and no. 80548Q100 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
    734
  • 날짜
    2003-07-05
  • 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 there are any batches in your stock. If you do, please contact ABBOTT LABORATORIOS DO BRASIL LTDA, by telephone 11 5367000 or your local representative, in order to make the return and consequently the replacement of the same. The UTVIG - Technovigilance Unit is monitoring the entire collection, return and replacement process until it closes.
  • 원인
    Test determined that the prolactin concentration in axsym batches mastes calibrators, prolactin calibrators, prolactin controls and imx mode 1 may have decreased by approximately 20%. imx mode 1 is a component of the imx reagent kit. decreased prolactin concentration in the calibrators may cause a change in the values ​​of the controls and a rise in patient outcomes. this change can be observed with abbott controls and multi-constituent controls from other manufacturers. there is a possibility that patient outcomes may have been elevated by approximately 20%.
  • 조치
    Collection and segregation for dissolution. Batches 75255Q100, 7813Q100, 75256Q100 and 78020Q100 have expired. A customer communication letter has been sent to all AxSYM and IMx customers who received the lots distributed in Brazil. Expiration dates for future batches of calibrators and controls will be redetermined to ensure acceptable product performance until the expiration date of the Material. Research to determine the cause of this decrease in concentration is under way.

Device

PROLATIN KIT OF AxSYM and IMx - PROLACTIN CALIBRATES Reg. No. 10055311055 n ° list 9C07-01 - Lots...

Manufacturer

ABBOTT LABORATÓRIOS DO BRASIL LTDA
  • Source
    ANVSANVISA