Events

CHOLINESTERASE FS (COLINESTERASE FS) Technical Name: COLINESTERASE Registration Number ANVISA: 10350840138 Hazard Class: II Affected Model: R1: 5 x 20 mL / R2: 1 x 25 mL Serial Numbers Affected: 60109928 의 안전성 경고

Agência Nacional de Vigilância Sanitária (ANVISA)에 따르면, 해당 안전성 경고 는 Brazil 에서 BIOSYS LTDA; DiaSys Diagnostic Systems GmbH 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
    2130
  • 날짜
    2016-12-19
  • 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
    Customers / users who have purchased the batch related to this notification are directed to segregate all units of the product as nonconforming product and returned to our care, for later replacement by another suitable batch. It is further recommended that the results eventually measured with the quoted batch be checked using another batch number. #### Update of the field action: UPDATED ON 10/16/2017, the company presented the report of completion of the field action, with sending evidence of the collection and destruction of the affected products.
  • 원인
    Biosys ltda., the record holder of the referenced product, received a communication from the international manufacturer of the same, diasys diagnostic systems gmbh, stating that of the product colinesterase fs lot 60109928 had to be withdrawn from the market due to a failure in the packaging process of the product. reagent r2 and the units already marketed should be collected. due to failure of the r2 container both patient and control samples will show false low results or even an error report in the results to and process the enasio in automatic machines. biosys informs that it has not received a customer complaint related to the product in question.
  • 조치
    Field Action Code 4130 triggered under the responsibility of the company BIOSYS LTDA. Company will collect for further destruction.

Device

CHOLINESTERASE FS (COLINESTERASE FS) Technical Name: COLINESTERASE Registration Number ANVISA: 10...

Manufacturer

BIOSYS LTDA; DiaSys Diagnostic Systems GmbH
  • Source
    ANVSANVISA