Events

Device Recall CHROMagar 의 리콜

U.S. Food and Drug Administration에 따르면, 해당 리콜 는 United States 에서 DRG International 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
    53841
  • 사례 위험등급
    Class 2
  • 사례 연번
    Z-1068-2010
  • 사례 시작날짜
    2009-11-09
  • 사례 출판 날짜
    2010-03-11
  • 사례 상황
    Terminated
  • 사례 국가
    United States
  • 사례 종료 날짜
    2012-05-14
  • 사례 출처
    USFDA
  • 사례 출처 URL
    https://www.accessdata.fda.gov/scripts/cdrh/cfdocs/cfres/res.cfm?id=86650
  • 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, antimicrobal susceptibility test, excluding mueller hinton agar - Product Code JSO
  • 원인
    Chromagar products are labeled incorrectly. label currently states that the product is for ivd use, when it should state that the product is intended for research use, not for use in diagnostic procedures.
  • 조치
    Two recall letters were sent via certified mail to customers. One letter was dated November 9, 2009 referencing the CHROMagar VRE product and the other letter dated November 12, 2009 referencing the CHROMagar 0157 product. The letters describe the affected product, problem, and action to be taken by the customer. The customers are to please STOP the use or distribution of the listed products and IMMEDIATELY examine your stock and return any un-expired CHROMagar product slated for recall for replacement the DRG International, Inc. The customers are being requested to please fill out and return the disposition sheet even if you have none of these items on hand since the information is important. If you have any questions, please contact customer service at (908) 233-0758.

Device

Device Recall CHROMagar
  • 모델명 / 제조번호(시리얼번호)
    Catalog numbers EE220, EE222, all lots within expiry.
  • 의료기기 분류등급
    Immunology and Microbiology Devices
  • 의료기기 등급
    2
  • 이식된 장치?
    No
  • 유통
    Nationwide distribution
  • 제품 설명
    CHROMagar 0157; || 5000 ml (29.2 g/L) || EE222; IVD || For In Vitro Diagnostic Use, CHROMagar is a trademark of Dr. A. Rambach; CHROMagar, Paris France. || Medium for the detection of Van A Van B VRE. The majority of customers use this product for food, environmental, research or veterinarian use.
  • Manufacturer
    DRG International Inc

Manufacturer

DRG International Inc
  • 제조사 주소
    DRG International Inc, 1167 US Highway 22, Mountainside NJ 07092-2807
  • 제조사 모회사 (2017)
    Drg International Inc
  • Source
    USFDA