Events

Name of products: Immunodiagnostic reagent Vitros for Syphilis TPA, ANVISA Registry 80145901397. Classification IV. 7,400 affected units were imported by Brazil, of which 4,300 were distributed in the Brazilian market. Only one product code was affected (6842803), and the lots and distribution site 0514 (300 units in Belo Horizonte MG, 100 units in Tangará da Serra-MT, 2,900 units in Curitiba-PR, 100 units Campos dos Goytacazes-RJ and 100 units in São Gonçalo-RJ), 0515, 0520 (700 units in Campos dos Goytacazes-RJ and 100 units in Piracicaba), 0531 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
    1893
  • 날짜
    2016-05-09
  • 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
  • 원인
    Potential for inability to obtain a valid calibration when using vitros reagent kits for syphilis tpa, lots 0514, 0515, 0520 and 0531. ortho's investigation has confirmed that these batches of the vitros syphilis tpa reagent kit have met the warranty release specifications of quality. however, upon release, these batches exhibited a reduction in the reaction signal to the level of calibrator 1. initial tests indicate that the unexpected signal decrease is related to a specific batch of feedstock used in the manufacture of the product. as a result of this problem, you should discontinue use of the product and discard the affected lots.
  • 조치
    Action code 16000062. Discontinue use and discard any remaining inventory of VITROS Reagent Kits for Syphilis TPA, Lots 0514, 0515, 0520 and 0531 and corresponding calibrators. (Manufacturer's Note: If the laboratory can successfully calibrate affected batches, and QA results are acceptable, the laboratory may continue to use the affected batches until it receives its replacement request.) Forward this notification if Kits have been provided of VITROS Reagent for Syphilis TPA, Lots 0514, 0515, 0520 and 0531 for other people outside your facility. Place this notification next to each VITROS® System that processes the VITROS Reagent Kits for Syphilis TPA.

Device

Name of products: Immunodiagnostic reagent Vitros for Syphilis TPA, ANVISA Registry 80145901397. ...

Manufacturer

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