Events

Device Recall Premier Toxin A 의 리콜

U.S. Food and Drug Administration에 따르면, 해당 리콜 는 United States 에서 Meridian Bioscience 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
    25295
  • 사례 위험등급
    Class 2
  • 사례 연번
    Z-0463-03
  • 사례 시작날짜
    2002-12-26
  • 사례 출판 날짜
    2003-01-23
  • 사례 상황
    Terminated
  • 사례 국가
    United States
  • 사례 종료 날짜
    2004-03-29
  • 사례 출처
    USFDA
  • 사례 출처 URL
    https://www.accessdata.fda.gov/scripts/cdrh/cfdocs/cfres/res.cfm?id=25556
  • 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
    Antigen, C. Difficile - Product Code MCB
  • 원인
    Due to defective packaging, the firm cannot assure product stability through the labeled expiration date.
  • 조치
    The firm mailed notices to their affected customers on 12/26/2002. The consignees were instructed to visually and physically inspect the seals on each microwell pouch for gaps. If properly sealed, the use of the microwells may be continued. Test wells in pouches with defective seals are to be quarantined and destroyed. The customers are asked to report back to the firm. All test microwell plates in defective pouches will be replaced by the firm.

Device

Device Recall Premier Toxin A
  • 모델명 / 제조번호(시리얼번호)
    Lot #601096.180, Exp Date 27 SEP 03;  Kit Catalog #601096.
  • 의료기기 분류등급
    Immunology and Microbiology Devices
  • 의료기기 등급
    1
  • 이식된 장치?
    No
  • 유통
    The kits were distributed to end-users and distributors located nationwide; and to foreign distributors located in China, Guatemala, New Zealand, Hong Kong, Mexico, Great Britain, Belgium, Italy, Brazil, Australia, Canada, Thailand, Honduras, and Japan.
  • 제품 설명
    Premier brand C. difficile Toxin A, diagnstic test kits, one kit per pouch, one pouch per shipping box.
  • Manufacturer
    Meridian Bioscience Inc

Manufacturer

Meridian Bioscience Inc
  • 제조사 주소
    Meridian Bioscience Inc, 3471 River Hills Dr, Cincinnati OH 45244
  • Source
    USFDA