Events

VITROS IMMUNODIAGNOSIS CALIBRATOR * ECi FOR TSH - registration 10132590384 (code: 1487289) and VITROS ECI FOR IMMUNODIAGNOSTIC REAGENT KIT FOR TSH - Registration 10132590403 (code: 1912997) - Lot 4540. See Annex 1 - Distribution List 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
    1415
  • 날짜
    2014-08-13
  • 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
    The manufacturer informs that according to international regulations, this event falls into a situation in which the use of, or exposure to, the affected product is unlikely to result in adverse health effects. The inability to generate successful calibration with VITROS® TSH Calibrators and Reagent Packs, Lot 4540 only affects the VITROS® 5600 and VITROS® 3600 Systems. If the laboratory has successfully calibrated the VITROS® TSH Calibrators and Reagent Packs products, Lot 4540 , the VITROS® 5600 and / or VITROS® 3600 System and the quality control results are acceptable, there will be no impact on patient outcomes.
  • 원인
    Ortho clinical diagnostics (ocd) has received complaints from customers who failed to generate a successful calibration using vitros® tsh calibrators and reagent packs, lot 4540, on the vitros® 5600 and 3600 systems. the company reports that it has not received calibration failures on the vitros® eci / eciq systems.
  • 조치
    The company informs that: i - If the laboratory has a VITROS® ECi / ECiQ System, it is possible to continue using VITROS® TSH Calibrators and Reagent Packs, Lot 4540, in the VITROS® ECi / ECiQ System. The OCD recommends that you allocate the remaining inventory of Lot 4540 for use only in the VITROS® ECi / ECiQ System; ii - If the laboratory has only VITROS® 5600 and / or VITROS® 3600, OCD will credit the account or replace the remaining customer inventory of VITROS® TSH Calibrators and Reagent Packs, Lot 4540 if you are unable to use this lot in a VITROS® ECi / ECiQ System; iii- If you have successfully calibrated VITROS® TSH Calibrators and Reagent Packs, Lot 4540, you can continue to use the current inventory until you receive the replacement product as long as the quality control results for TSH are acceptable; iv - To avoid this failure again in the future, discontinue use and dispose of all VITROS® TSH Calibrators and Reagent Packs, Lot 4540, after receiving the replacement product. For more information, please check the Letter to the Client - Annex II

Device

VITROS IMMUNODIAGNOSIS CALIBRATOR * ECi FOR TSH - registration 10132590384 (code: 1487289) and VI...

Manufacturer

Johnson & Johnson do Brasil Ind. e Com. de Prod. para Saúde Ltda; Ortho-Clinical Diagnostics