Events

Trade name: 31 Vitros Calibrator Kit. Registration number ANVISA: 80145901715. Technical Name: Glycated hemoglobin. Risk class: Product classified as II and the control of these systems is performed by lot number. Affected model: 119 calibration kit units have been imported that together with the Assay Data Diskette (ADD) versions 5873, 5874, 5875 and 5876 will not be possible to calibrate 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
    1926
  • 날짜
    2016-05-19
  • 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
    According to the company, users who own the batch affected by this field action should: • Install the DRV 5877 Assay Data Diskette or later on their VITROS System. After successful calibration and quality control evaluation, it is acceptable to use the VITROS Reagent Kit for HbA1c, GEN 06. NOTE: For electronically connected systems, automatic download was available as of April 12, 2016.
  • 원인
    Impossibility to calibrate the vitros® chemistry products reagent kit for hba1c, generation (gen) 06, when using the vitros calibrator kit, lot 3155 and specific assay data diskettes (5873, 5874, 5875 and 5876). it should be noted that the assay data diskette (add) drv 5877 and later contain the correct calibration data. ortho clinical diagnostics (ortho) has detected an incorrect value (calibration data / mathematics) in the adds listed above for the vitros 31 calibrator kit, lot 3155, used to support the vitros reagent kit for hba1c, gen 06. the value incorrect calibration will prevent successful calibration of the test.
  • 조치
    Action required for laboratories that have the affected lot: • Install the Assay Data Diskette DRV 5877 or later on your VITROS System. After successful calibration and quality control evaluation, it is acceptable to use the VITROS Reagent Kit for HbA1c, GEN 06. NOTE: For electronically connected systems, automatic downloading has been available since April 12, 2016. This is a situation where the use of the product is not likely to cause adverse health consequences. Cod. 16000096 - Letter to clients in ANNEX

Device

Trade name: 31 Vitros Calibrator Kit. Registration number ANVISA: 80145901715. Technical Name: Gl...

Manufacturer

Johnson & Johnson do Brasil Ind. e Com. de Prod. para Saúde Ltda; ORTHO CLINICAL DIAGNOSTICS, INC