remel Haemophilus Test Medium (Agar) 의 리콜

U.S. Food and Drug Administration에 따르면, 해당 리콜 는 United States 에서 Remel 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
    58684
  • 사례 위험등급
    Class 2
  • 사례 연번
    Z-2929-2011
  • 사례 시작날짜
    2011-04-21
  • 사례 출판 날짜
    2011-08-03
  • 사례 상황
    Terminated
  • 사례 국가
  • 사례 종료 날짜
    2013-06-21
  • 사례 출처
    USFDA
  • 사례 출처 URL
  • 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
    Culture media, antimicrobial susceptibility test, excluding mueller hinton agar - Product Code JSO
  • 원인
    Organism strains may fail to consistently produce confluent growth.
  • 조치
    The firm, Remel, Inc., sent two "IMPORTANT MEDICAL DEVICE PRODUCT RECALL NOTICE" letters one dated April 20, 2011 to: Microbiology Lab Supervisors and the second dated April 25, 2011 to:Distributors via regular mail. The letters described the product, problem and actions to be taken. The customers were instructed to to review their inventory for the listed product lot(s); discard all remaining units of the product lots; and complete and return the Product Inventory Checklist by May 9, 2011 regardless if they have affected product in the enclosed self-addressed, stamped envelope. The distributors were further instructed to notify their customers if they further distributed the product. If you have inquiries concerning this advisory, please contact our Technical Services Department at 800-255-6730 or 913-888-0939.

Device

  • 모델명 / 제조번호(시리얼번호)
    Lot 017075, Exp. 2011.04.18; lot 018116, Exp. 2011.04.21; Lot 020358, Exp. 2011.04.27; lot 023750, Exp. 2011.05.04; and lot 023851, Exp. 2011.05.05.
  • 의료기기 분류등급
  • 의료기기 등급
    2
  • 이식된 장치?
    No
  • 유통
    Nationwide distribution.
  • 제품 설명
    remel Haemophilus Test Medium (Agar), 150mm plates, 10/pk, Ref. #R04033. The firm name on the label is Remel, Lenexa, KS. || For use in qualitative procedures by the Clinical and Laboratory Standards Institute (CLSI) as the growth medium for antimicrobial disk diffusion tests with Haemophilus species.
  • Manufacturer

Manufacturer