Thermometer medical maximum glass mercury (coated / uncoated) TU 944-033-402-2008 를 위한 리콜 또는 안전성 경고

Ministry of Health of the Republic of Belarus에 따르면, 해당 리콜 또는 안전성 경고 는 Belarus 에서 JSC "Termopribor" Klin, RUSSIA 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
    Recall / Safety alert
  • 사례 연번
    ИМ-7.101982
  • 날짜
    2016-05-19
  • 사례 국가
  • 사례 출처
    MHRB
  • 사례 출처 URL
  • 비고 / 경고
    Belarussian data is current through June 2016. All of the data comes from Health Canada, 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 recall data from the U.S. and Belarus.
  • 데이터 추가 비고
  • 원인
    According to the certificate of expertise dated april 20, 2016, ojsc thermopribor, the main distinguishing features of the original thermometer from the counterfeit one are: 1. thermometer scale: marking on the scale of the counterfeit thermometer is printed in a larger font than in the original thermometer. on all scales of thermometers produced by odo “thermopribor” on the reverse side of the top there is a scale number. on counterfeit products - no digital scale. 2. verification mark: the mark of a counterfeit thermometer is distinguished by its type and size. the stamp of a counterfeit thermometer is applied in another way, the glass at the site of application of the stamp to the touch has a rough surface, on the original thermometers - smooth. the image of the stamp has clear boundaries, on the original "blurry". 3. case: in the original thermometer - semicircular, in counterfeit - square. a color copy of the examination certificate dated april 20, 2016 of ojsc “termopribor” is on the website of the ue “center for expertise and testing in health care” www.Rceth.By in the section “safety and quality of medical products” http://www.Rceth.By/ com / safety / medsafety. in connection with the above, in accordance with clause 8.16 of the statute on the ministry of health of the republic of belarus, approved by decree of the council of ministers of the republic of belarus of 28.10.2011 no. 1446 (as amended on 27.12.2012) “on some issues of the ministry of health and measures to implement the decree of the president of the republic of belarus dated august 11, 2011 no. 360 »the ministry of health of the republic of belarus exercises state control over the quality of medical devices and medical equipment when health facilities are available pharmacy network, business entities of non-state ownership of counterfeit products: medical thermometer maximum glass mercury (coated / uncoated) tu 944-033-402-2008, produced by termopribor klin, russia, these medical products must be returned to the supplier product and inform the ue "center for expertise and testing in health care", at: friendly 2a, minsk, 220037.

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