Events

Device Recall Signify hCG Serum/Urine 30 Test Kit 의 리콜

U.S. Food and Drug Administration에 따르면, 해당 리콜 는 United States 에서 Applied Biotech Inc 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
    35542
  • 사례 위험등급
    Class 2
  • 사례 연번
    Z-1100-06
  • 사례 시작날짜
    2006-05-05
  • 사례 출판 날짜
    2006-06-09
  • 사례 상황
    Terminated
  • 사례 국가
    United States
  • 사례 종료 날짜
    2012-02-29
  • 사례 출처
    USFDA
  • 사례 출처 URL
    https://www.accessdata.fda.gov/scripts/cdrh/cfdocs/cfres/res.cfm?id=46365
  • 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
    Visual, Pregnancy Hcg, Prescription Use - Product Code JHI
  • 원인
    Certain kits from the product lot may contain test devices which contain incorrect reaction strips. use of such devices may produce false negative results with patient samples at and above the limit of detection of the product.
  • 조치
    Distribution records indicate that the above product lot was produced for sale to Abbott Laboratories and Abbott Laboratories received all of the product lot. A recall certified recall letter was mailed 05/08/06. Abbott was also instructed if they have further distributed any of the referenced product lot, please see that their accounts are contacted, advise them of the urgent notification, and instruct them to destroy any of the affected product lot.

Device

Device Recall Signify hCG Serum/Urine 30 Test Kit

Manufacturer

Applied Biotech Inc
  • 제조사 주소
    Applied Biotech Inc, 10237 Flanders Ct, San Diego CA 92121-2901
  • Source
    USFDA