Events

GSP Genetic Screening Processor Technical Name: ANVISA Registration Number: 10298910108 Hazard Class: I Affected Model: 2021-0010 Affected serial numbers: 20210154, 20210207, 20210171, 20210163, 20210161, 20210208. 의 안전성 경고

Agência Nacional de Vigilância Sanitária (ANVISA)에 따르면, 해당 안전성 경고 는 Brazil 에서 PerkinElmer do Brasil Ltda.; Wallac Ou 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
    2193
  • 날짜
    2016-09-02
  • 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
    Defective insulation will be replaced during the next scheduled periodic maintenance visit or service visit. The visit can also be scheduled if requested by the client.
  • 원인
    We are aware that the insulation of the heated incubator door is defective in the instrument serial numbers listed above due to a change in the insulation production method. the film may come loose from the outer surface of the insulation, causing a mechanical motion error or a temperature control error. due to the defect, the instrument's operations will stop and it will require repair by perkinelmer field service engineers. instrument performance is only affected when error occurs in mechanical movement or temperature control. the operation of the heated incubator is involved during the incubation steps of the gsp neonatal galt (3303-0010 and 3303-001u) and gsp neonatal biotinidase (3307-0010, 3307-001u) assays which require a high temperature (+ 37 ° c ). the functionality of the heated incubator door is also checked during the instrument start procedure.
  • 조치
    Field Action Code 2016.06.005461 triggered under the responsibility of the company PerkinElmer do Brasil Ltda. Company will make correction in the field.

Device

GSP Genetic Screening Processor Technical Name: ANVISA Registration Number: 10298910108 Hazard Cl...

Manufacturer

PerkinElmer do Brasil Ltda.; Wallac Ou