Events

ATB - DENSITOMETER CONTROL DEVICE, Mark: Biomerieux, Registration: 10158120674, lots 1003780430, 1003838260, 1003848040, 1003883560, 1003990940, 1004089920. 의 안전성 경고

Agência Nacional de Vigilância Sanitária (ANVISA)에 따르면, 해당 안전성 경고 는 Brazil 에서 Biomerieux Brasil SA.; Biomerieux S. A 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
    1746
  • 날짜
    2015-11-12
  • 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
    According to the company the problem may cause a failure to control the calibration of the Densimat instrument, potentially leading to false susceptibility or false identification results. ### Update of the field action: UPDATED ON 07/28/2017, the company presented the completion report of the field action proving the sending of the safety notice to the client and destination of the nonconforming products.
  • 원인
    Performance failure, with change in performance, in the lots described for the product atb- densitometer control device. in this case, the calibration check of the densimat equipment may fail.
  • 조치
    The company will collect and destroy the products. A letter will be forwarded to all customers who have purchased the affected lots, with detailed guidance on how to proceed with the product covered by this field action. The company directs you to stop using the affected product and fill out the Notification form to notify the company of any remaining stock of the kit. The company's recommendation is that until the manufacturing of new lots, the Mc Farland standard scale can be used as a back-up solution. A new batch of the product was released to replace the nonconforming product. Additional batches will be available for allocation until the breach situation is resolved. As soon as stock is normalized, bioMérieux will contact customers.

Device

ATB - DENSITOMETER CONTROL DEVICE, Mark: Biomerieux, Registration: 10158120674, lots 1003780430, ...

Manufacturer

Biomerieux Brasil SA.; Biomerieux S. A