VANG VITROS REAGENT KIT Technical Name: VANCOMICINE ANVISA Registration Number: 80145900812 Hazard Class: II Affected Model: Box with 6 kits (Reagent 1: 9.7ml / Reagent 2: 4.9ml) Lot / Serial Numbers affected: SKU 6801709, lot 315506 의 안전성 경고

Agência Nacional de Vigilância Sanitária (ANVISA)에 따르면, 해당 안전성 경고 는 Brazil 에서 Johnson & Johnson do Brasil Ind. e Com. de Prod. para Saúde Ltda; Ortho-Clinical Diagnostics, Inc. 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
    2261
  • 날짜
    2017-04-11
  • 사례 국가
  • 사례 출처
    ANVISA
  • 사례 출처 URL
  • 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
    • Immediately discontinue use and dispose of all remaining inventory of VITROS VANC Reagent Packs for the affected lots listed above. NOTE: If you do not have an alternate lot in your inventory, refer to the information provided on page three for instructions on using your current lot until the replacement products arrive. • Complete and return the Receipt Confirmation. • Place this notification next to each VITROS System that uses the VITROS VANC Reagent Packs products or together with your user documentation
  • 원인
    Ortho clinical diagnostics (ortho) has identified the potential for deviated results generated by using the vitros vanc reagent product for the lots indicated above. this may occur after loading the reagent kits into the analyzer and storing them for the duration of stability in the analyzer. some clients observed a positive standard deviation (sd) of> 2 in the quality control results when using vitros tdm performance verifiers (levels i, ii and iii).
  • 조치
    Field Action Code TC2017-041 triggered under the responsibility of Johnson & Johnson do Brasil Ind. And Com. De Prod. for Health Ltda. Company will make correction in the field.