Events

Trade name: Kit Reag Immunodiag Vitros p PTH Intacto (iPTH); Calibrad Immunodiag VITROS p PTH Intact (iPTH) Technical name: intact parathyroid hormone (iPTH); Intact Parathyroid Hormone (iPTH) ANVISA Registration Number: 80145901321 Hazard Class: II Model Affected: Reag Immunodiag Vitros p PTH Intact (iPTH); Calibrad Immunodiag Vitros p Intact PTH (iPTH) Serial numbers affected: 0700, 0710, 0748, 0758 // Immunoassay Calibrator Vitros for Intact PTH (iPTH); product code 6802893; lots: 0728, 0738, 0768. 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
    2111
  • 날짜
    2016-10-31
  • 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
    • Until further notice, be aware of positive deviation results when using VITROS Reagent Kits for iPTH. • Talk to the Laboratory Medical Director about any questions regarding previously reported results to determine the appropriate course of action. • Place this notification on your VITROS System or along with your user documentation. • In compliance with regulatory requirements, complete the Receipt Confirmation Form.
  • 원인
    Ortho clinical diagnostics (ortho) has confirmed that the results obtained from the vitros reagent kit for ipth show positive (ie, falsely elevated) deviations compared to a commercially available alternative method. ortho observed a 40% positive shift for samples with ipth concentrations <100pg / ml, when tested with vitros reagent kits for ipth, compared to the roche elecsys pth test. the data demonstrated that this deviation was consistent across all batches still valid. due to the limited availability of samples with ipth concentrations> 100 pg / ml, the investigation may take several weeks to complete. in the best interest of clients and patients, ortho reports the preliminary results and will provide additional notifications when the final results are available.
  • 조치
    Field action Code 16000147 triggered under the responsibility of Johnson & Johnson do Brasil Ind. And Com. De Prod. for Health Ltda. Company will make correction in the field.

Device

Trade name: Kit Reag Immunodiag Vitros p PTH Intacto (iPTH); Calibrad Immunodiag VITROS p PTH Int...

Manufacturer

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