Trade name: Family E-Check- Sysmex (Xn Check). Technical name: Combined parameters in the same product. ANVISA registration number: 80015490061. Class of risk: II. Affected Model: 12 Vials X3.0 Ml of Each Level (Level 1, Level 2, Level 3). Serial number affected: 7320, 8011, 8067 의 안전성 경고

Agência Nacional de Vigilância Sanitária (ANVISA)에 따르면, 해당 안전성 경고 는 Brazil 에서 Sysmex Do Brasil Indústria E Comércio Ltda; Sysmex Corporation 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
    2504
  • 날짜
    2018-02-28
  • 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
    Customers who purchased the batches of affected product were contacted via email, phone call and also mail, which explained about the change of purchased lots. In this recommendation the laboratories were advised that they can check the accuracy of the analyzer using fresh normal whole blood. For specifications, refer to the Accuracy (Repeatability) section in the Technical Information section of the Analyzer Instructions for Use. Customers were also informed that no replacement of control material is recommended at this time; and that they must distribute this Product Notice as appropriate to their laboratory staff. Finally, it was recommended to file this Product Notice as part of the Quality System of your laboratory. LETTER OF COMMUNICATION WITH THE RECOMMENDATIONS TO THE CUSTOMER IN ANNEX. If you wish to notify technical complaints and adverse events use the following channels: Notivisa: Notices of adverse events (AE) and technical complaints (QT) for products subject to Sanitary Surveillance should be made through the NOTIVISA System. To access the System, you must register and select the Health Professional option, if you are a liberal professional or the Institution / Entity option, if you are a professional of an institution / entity. Technovigilance System: Patient or citizen can notify through the Technovigilance System / SISTEC access through the link Additional information: - Date of identification of the problem by the company: 01/16/2018 - Date of notification notice for Anvisa: 02/23/218 The company that owns the affected product is responsible for contacting its customers in a timely manner. to ensure the effectiveness of the Field Action in progress. It stands out the joint responsibility of the distribution chain and use of health products in maintaining its quality, safety and efficacy, as well as the effectiveness of the Field Action, expressed by RDC 23/2012: "(...) Art 2 ° A holder of registration of health product is the holder of the registration / registration of health product with Anvisa. Single paragraph. The registration holder, as well as other agents involved from the production to the use of the product, or discarding it when applicable, are jointly and severally responsible for maintaining the quality, safety and efficacy of the health products to the final consumer. Art. 12 Distributors of health products shall forward to the registration holder, in a timely manner, the distribution map and other information requested for the notification and execution of field actions. (...) "
  • 원인
    The company identified an increase in inaccuracy of lymphocyte counts (lym #, lym%) and monocytes (mono #, mono%) with the xn check hematology control. preliminary research suggests that cell populations are positioned near the threshold for the separation of lymphocytes and monocytes at all levels of xn-check. this position is a result of the ages of the component cells and not of product instability. the question causes more variability in quality control results or higher coefficients of variation (cv%) for lym% / #, and mono% / #. the other parameters of the test sheet are not affected. patient outcomes are also unaffected.
  • 조치
    Field Action Code CAPA.0029 triggered under the responsibility of the company Sysmex do Brasil Indústria e Comércio Ltda. Will make field correction

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