Events

Calibration Data Module 의 안전성 경고

Department of Health에 따르면, 해당 안전성 경고 는 Hong Kong 에서 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
  • 날짜
    2014-02-07
  • 사례 출판 날짜
    2014-02-07
  • 사례 국가
    Hong Kong
  • 사례 출처
    DH
  • 사례 출처 URL
    https://www.mdco.gov.hk/english/safety/recalls/recalls_20140207a.html
  • 비고 / 경고
    Hong Kong data is current through September 2018. All of the data comes from the Department of Health (Hong Kong), 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 Hong Kong.
  • 데이터 추가 비고
    Medical Device Safety Alert
  • 원인
    Medical device safety alert: ortho clinical diagnostics calibration data module medical device manufacturer, ortho clinical diagnostics, has issued a medical device safety alert concerning its calibration data module (cdm prom) [affected lot: 0168 catalogue number: 1999077]. a cdm prom is an electronic device that contains data required to perform various tests on the vitros dt60/dt60 ii chemistry systems. according to the manufacturer, this product correction notification has been initiated due to an inability to calibrate or use vitros crsc dt slides, gen 82 when using cdm prom 0168. calibration data module (cdm prom) 0168 contains data that allows the use of new lots of vitros dt slides and vitros dt calibrator kits on vitros dt60/dt60 ii chemistry systems. this cdm prom was sent to all customers beginning in october 2013. the manufacturer has received complaints for the inability to calibrate or subsequently use vitros crsc dt slides, gen 82 after the installation of cdm prom 0168. according to the local supplier, the affected products were not distributed in hong kong. if you are in possession of the affected products, please contact your supplier for necessary actions. posted on 07 february 2014.

Device

Calibration Data Module
  • 모델명 / 제조번호(시리얼번호)
  • 제품 설명
    Medical Device Safety Alert: Ortho Clinical Diagnostics Calibration Data Module
  • Manufacturer
    Ortho Clinical Diagnostics

Manufacturer

Ortho Clinical Diagnostics