Events

Device Recall Diagnostic Chemicals Limited 의 리콜

U.S. Food and Drug Administration에 따르면, 해당 리콜 는 United States 에서 Diagnostic Chemicals, Ltd. 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
    37011
  • 사례 위험등급
    Class 2
  • 사례 연번
    Z-0361-2007
  • 사례 시작날짜
    2006-12-05
  • 사례 출판 날짜
    2007-01-23
  • 사례 상황
    Terminated
  • 사례 국가
    United States
  • 사례 종료 날짜
    2016-01-27
  • 사례 출처
    USFDA
  • 사례 출처 URL
    https://www.accessdata.fda.gov/scripts/cdrh/cfdocs/cfres/res.cfm?id=49757
  • 비고 / 경고
    U.S. data is current through June 2018. All of the data comes from the U.S. Food and Drug Administration, except for the category Manufacturer Parent Company.
    The Parent Company was added by ICIJ.
    The parent company information is based on 2017 public records.
  • 데이터 추가 비고
    in vitro diagnostic - Product Code DKJ
  • 원인
    Upon subsequent testing on different instruments (as required by other customers), dcl detected a non-linear response on certain analyzers. a decision was made to recall the product due to the fact that dcl customers sell the product to different end users, dcl cannot be certain which instruments the end users employ in their laboratories.
  • 조치
    For product shipped by DCL to one customer notification letter dated 12/5/06 sent out to customer to return/discard product. Replacement will be sent to customer. For product shipped to DCL (USA) warehouse notification sent to discard kits remaining in stock. For product remaining at DCL Canada in-house notification sent out to discard in-house kits.

Device

Device Recall Diagnostic Chemicals Limited

Manufacturer

Diagnostic Chemicals, Ltd.
  • 제조사 주소
    Diagnostic Chemicals, Ltd., 16 McCarville Street, Charlottetown Canada Prince Edward Island
  • Source
    USFDA