Name of products: Calibrator Kit 29 Vitros *. Technical Name: Total Iron Connection Capacity (TIBC). Registration number: 80145900910. Product code 6802344. Lots affected and imported into Brazil: 2915; 2995. 89 reagent kit units were imported 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 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
    1956
  • 날짜
    2016-07-12
  • 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
    This is a situation in which the use of the product is not likely to cause adverse health consequences. Action Required for Laboratories that Own the Affected Lot: • As soon as available, install ADD DRV 5884 or later on your VITROS system. • E-Connected Systems: Automatic download will be available in early May 2016. • ADD DRV 5884 or later will also be shipped to your facility upon availability. NOTE: After loading ADD DRV 5884 or later for the first time, the VITROS dTIBC GEN 30 Reagent will lose the calibration and must be recalibrated. • After successful calibration and quality control evaluation, it is acceptable to use your remaining inventory of the VITROS dTIBC, GEN 30 Reagent. • Place this notification on your VITROS System or along with your user documentation. • Fill out and return the Receipt Confirmation form If you have any questions regarding this field action, please contact Johnson & Johnson do Brasil Ind. And Com. De Prod. for Health Ltda. by telephone: 12 3932-7977 or e-mail: gbuosi@its.jnj.com
  • 원인
    The manufacturer has detected that there are incorrect values ​​(data / calibration math) on assay data diskettes (add) for calibrator kit 29, which supports the vitros dtibc, gen 30 reagent. incorrect values ​​will cause a positive trend in the sample results (ie, patient samples, proficiency fluids, and quality control fluids).
  • 조치
    Field Action No. 16000095 triggered under the responsibility of Johnson & Johnson do Brasil Ind. And Com. De Prod. for Health Ltda. Action Required for Laboratories that Own the Affected Lot: • As soon as available, install ADD DRV 5884 or later on your VITROS system. • E-Connected Systems: Automatic download will be available in early May 2016. • ADD DRV 5884 or later will also be shipped to your facility upon availability. NOTE: After loading ADD DRV 5884 or later for the first time, the VITROS dTIBC GEN 30 Reagent will lose the calibration and must be recalibrated. • After successful calibration and quality control evaluation, it is acceptable to use your remaining inventory of the VITROS dTIBC, GEN 30 Reagent. • Place this notification on your VITROS System or along with your user documentation. • Complete and return the Receipt Confirmation form