Events

AUTO D-DIMERO AMAX CRS126-B - Registered in Anvisa under the number 10071770465 - LOTS: T082003 / T084001 / T119006. 의 안전성 경고

Agência Nacional de Vigilância Sanitária (ANVISA)에 따르면, 해당 안전성 경고 는 Brazil 에서 Medlab Produtos Médico Hospitalares 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
    981
  • 날짜
    2009-09-17
  • 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
    Observe that the instructions for use of the product indicate that the results should be used with other clinical information and laboratory diagnosis, for the formation of the diagnosis and for the follow-up of the patient. Although it is estimated that the clinical risk is low, it is recommended that the end-user check the calibration curves and make the appropriate determination based on the use of the test and re-test any high sample whose result may be underestimated. Anvisa is following this field action.
  • 원인
    The company reports that after internal investigation, when the calibration curve was generated with the reference batches of the auto d-dimero amax crs126-b product, it was observed that there is a possibility that the two highest points of the curve are not distinguished from one of the and the very high values ​​of dimero d, although they remain high, can be underestimated. a research test showed that in some cases samples greater than 30,000 ng / ml fell within the calibration curve without dilution. there is no indication that this fact could cause an increase in the normal value of d-dimer.
  • 조치
    The actions recommended to users of the product are as follows: (1) Immediately stop using the product; (2) Locate the product with the affected batches in your inventory and segregate them. (2) Return them to the dealer for disposal. (3) Forward the Form for Verification and Traceability Response to Medlab Produtos Médico-Hospitalares Ltda. - A / C Luiz Alberto Marin - Phone: (011) 2131-5137 or e-mail luiz.marn@medlabgroup.com.br.

Device

AUTO D-DIMERO AMAX CRS126-B - Registered in Anvisa under the number 10071770465 - LOTS: T082003 /...

Manufacturer

Medlab Produtos Médico Hospitalares Ltda.
  • Source
    ANVSANVISA