Events

Ortho Vision Analyzer Technical Name: Immunohematology Equipment ANVISA Registration Number: 80145901739 Hazard Class: I Affected Model: Ortho Vision Analyzer Affected Series Numbers: ORTHO VISION® Cassette Analyzer ORTHO BioVue®, Product Code 6904579, Version of software 3.6.0 and earlier, Serial number 60002256 and 60002257. 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
    2115
  • 날짜
    2016-12-21
  • 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
    • Load and discharge only the samples, reagent or diluent using the wizard shown on the Samples or Reagents screen, according to the instructions in the ORTHO VISION Reference Guide. • After making a Load / Unload request, make changes only to the position of LOAD STATION, whose access was specifically requested in the GUI interface. • Place this notification on the ORTHO VISION Analyzer or together with the user documentation. • Complete and return the Receipt Confirmation form.
  • 원인
    In february and march 2016, ortho clinical diagnostics (ortho) issued an urgent notice of product correction to an improbable scenario, in which after making a reagent loading / discharging request, a user removes or swaps samples into a rack, removes or exchanges diluents, or removes a dilution rack from a location that has not been selected in the "graphical user interface (gui)" interface. note: brazil was not affected in the initial communication (february and march 2016). ortho is issuing this update for urgent product correction notifications because, after issuing the notifications, ortho has identified that a normal process deviation, when accessing any location in the loading station area (samples, reagents or diluents) does not specified in the interface (gui), may not be detected by the parser. the system does not re-scan the barcodes of the positions exposed to the user in any area of ​​the load station, different from the location requested in the gui interface.
  • 조치
    Field Action Code 16000170 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

Ortho Vision Analyzer Technical Name: Immunohematology Equipment ANVISA Registration Number: 8014...

Manufacturer

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