Events

PATHFAST CK-MB AND PATHFAST NTproBNP REAGENTS 의 안전성 경고

Food and Drug Administration Philippines에 따르면, 해당 안전성 경고 는 Philippines 에서 N/A 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 연번
    2018-206
  • 사례 국가
    Philippines
  • 사례 출처
    FDAP
  • 사례 출처 URL
    https://ww2.fda.gov.ph//index.php/advisories-2/medical-devices-advisories-pertaining-to-all-regulated-medical-devices/514569-fda-advisory-no-2018-206
  • 비고 / 경고
    Data from the Philippines is current through 2019. All of the data comes from the Food and Drug Administration Philippines, 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 Philippines.
  • 데이터 추가 비고
  • 원인
    Fda advisory no. 2018-206 voluntary recall of the pathfast ck-mb and pathfast ntprobnp reagents  all are hereby advised by the food and drug administration (fda) on the voluntary recall of pathfast ck-mb with lrd/cdrrhr_exemp-2015-6374 and pathfast ntprobnp with lrd/cdrrhr_exemp-2015-6372 distributed by global medical solutions, inc., with business address at 3/f 14 economia st., bagumbayan, quezon city with the following information: product name catalogue no. lot no. pathfast ck-mb pf1031-k 0769 pathfast ntprobnp                pf1061-k 0768 pathfast ntprobnp                pf1061-k 0769 the cited medical device was voluntarily recalled by global medical solutions, inc. due to the several reagent cartridges had tiny pinhole on the aluminum seal at the well position of alkaline phosphatase labelled antibody reagent which was generated during the filling process. in case the reagent leaked through the pinhole, the appropriate result may not be obtained. the above recalled medical device products might results in deviation of accuracy of the data if reagent leakage occurs through the pinhole.    distributors, retailers, hospitals that have any lot of the stated medical device product are instructed to discontinue further distribution, sale and use. all consumers are likewise advised not to purchase or use the affected product lots.  any suspected adverse reaction experienced or any incident of the same cases from the use of the device but not limited to the lots stated above, should be reported immediately to fda at telephone no. (02) 857-1900 loc. 8301 or email us at this email address is being protected from spambots. you need javascript enabled to view it. . dissemination of the information to all concerned is requested.      attachments: fda advisory no. 2018-206.Pdf.

Device

PATHFAST CK-MB AND PATHFAST NTproBNP REAGENTS
  • 모델명 / 제조번호(시리얼번호)
  • Manufacturer
    N/A

Manufacturer

N/A
  • Source
    FDAP