Events

Clearview hCG Combo 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
    44894
  • 사례 위험등급
    Class 2
  • 사례 연번
    Z-0245-2008
  • 사례 출판 날짜
    2007-11-21
  • 사례 상황
    Terminated
  • 사례 국가
    United States
  • 사례 종료 날짜
    2012-08-03
  • 사례 출처
    USFDA
  • 사례 출처 URL
    https://www.accessdata.fda.gov/scripts/cdrh/cfdocs/cfres/res.cfm?id=64584
  • 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
    hCG Combo - Product Code JHI
  • 원인
    Sensitivity: kits contain test devices which may not meet the label claims for sensitivity, therefore use of such devices may produce false negative results with patient samples at or near the limit of detection of the product.
  • 조치
    A Product Recall Notification dated 9/28/2006, was provided via fax, email or direct mail to all primary consignees. Customers were instructed to block all stock of affected lots in their warehouses, contact their primary consignees and advise them to discontinue use immediately and dispose of any unused materials; using a fax back form to communicate to the recalling firm the quantity blocked and disposed of so that arrangements could be made for providing replacement product

Device

Clearview hCG Combo
  • 모델명 / 제조번호(시리얼번호)
    Model Number 6026KCV; ABI Lot Code: 87494
  • 의료기기 분류등급
    Clinical Chemistry and Clinical Toxicology Devices
  • 의료기기 등급
    2
  • 이식된 장치?
    No
  • 유통
    Worldwide: USA and Canada
  • 제품 설명
    Clearview hCG Combo Waived for urine & Moderate for serum, Wampole Laboratories, ABI List No/Product No. 6026KCV; Contents 30 Individually pouched test cassettes with disposable pipettes, 1 Directional Insert; Inverness Medical Professional Diagnostics Group; Marketed by Wampole Laboratories, 2 Research Way, Princeton NJ 08540 USA
  • Manufacturer
    Applied Biotech Inc

Manufacturer

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