VITROS Chemistry Products Slide Assays - GLU, LAC, TRIG, URIC. An in vitro diagnostic medical device (IVD) 의 리콜

Department of Health, Therapeutic Goods Administration에 따르면, 해당 리콜 는 Australia 에서 Ortho-Clinical Diagnostics 에 의해 제조된 제품과 관련되어 있습니다.

이것은 무엇인가요?

의료기기에 문제가 생겼을 경우 제조사가 이를 바로잡거나 시장에서 회수하는 조치를 말한다. 회수(Recall)는 의료기기에 결함이 있거나, 건강에 위협이 되거나, 또는 결함도 있고 건강에도 위협이 될 경우에 발생한다.

데이터에 대해 더 자세히 알아보기 여기
  • 사례 유형
    Recall
  • 사례 ID
    RC-2016-RN-01118-1
  • 사례 위험등급
    Class II
  • 사례 시작날짜
    2016-08-25
  • 사례 국가
  • 사례 출처
    DHTGA
  • 사례 출처 URL
  • 비고 / 경고
    Australian data is current through July 2018. All of the data comes from the Australian Therapeutic Goods Administration, 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 Australia.
  • 데이터 추가 비고
  • 원인
    1. ortho clinical diagnostics (ortho) was made aware of new information regarding the potential for n-acetylcysteine (nac) to interfere with specific vitros chemistry products slide assays (glu, lac, trig and uric). patients who were administered nac could potentially have biased sample results. 2. ortho has also found that dextran 40 and glutathione may also interfere with vitros glu slides and cause biased results.To date, ortho is not aware of any misreported patient results associated with this issue all expired, current/in-date and future generations (gens) of the assays are affected.
  • 조치
    The Instructions for Use (IFUs) for the affected assays (GLU, LAC, TRIG, URIC) will be revised to include the interferent information in the Limitations of the Procedure section. Ortho is advising users that biased results may occur for patient sample containing these substances and is providing the results of the interference testing undertaken with these substances. The affected VITROS Slide Assays can continue to be used, with consideration of the new potential interferents. Any concerns regarding previously reported results should be discussed with the Laboratory Medical Director to determine the appropriate course of action.

Device

  • 모델명 / 제조번호(시리얼번호)
    VITROS Chemistry Products Slide Assays - GLU, LAC, TRIG, URIC. An in vitro diagnostic medical device (IVD)GLU SlidesProduct Code: 1707801Current/In-date Generations (GENs): 10, 11, 20 through 31LAC SlidesProduct Codes: 8433880, 8150112Current/In-date GENs: 30, 31TRIG SlidesProduct Codes: 1336544, 8329930Current/In-date GENs: 16, 17, 19, 20, 22, 23, 24, 25, 27 through 32URIC SlidesProduct Code: 1943927Current/In-date GENs: 26, 27, 28, 29, 31ARTG Number: 232248
  • Manufacturer

Manufacturer