Events

Device Recall Microbiologics KWIKQC SLIDES 의 리콜

U.S. Food and Drug Administration에 따르면, 해당 리콜 는 United States 에서 Microbiologics 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
    64469
  • 사례 위험등급
    Class 2
  • 사례 연번
    Z-1021-2013
  • 사례 시작날짜
    2013-02-11
  • 사례 출판 날짜
    2013-03-28
  • 사례 상황
    Terminated
  • 사례 국가
    United States
  • 사례 종료 날짜
    2016-03-10
  • 사례 출처
    USFDA
  • 사례 출처 URL
    https://www.accessdata.fda.gov/scripts/cdrh/cfdocs/cfres/res.cfm?id=116205
  • 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
    Quality control slides - Product Code LJG
  • 원인
    Microbiologics inc is initiating a voluntary recall on products kwik-qc acid fast stain slide, sl42-10 and kwik-qc mycobacterium, sl43-10. these products are being recalled because the control organisms are not properly fixated on the slide, which may cause the user to unintentionally contaminate the patient area of the slide by flooding the control well with stain. this contamination could pote.
  • 조치
    Microbiologists an "Urgent Medical Device Recall" letter dated February 11, 2013. The Letter described the product and the reason for the recall. Advised consignees to "Do not Distribute" and "Return" the product. Urged consignees to "Notify" end users and to complete the attached "Recall Response Form". Contact the form at 320-229-7057 for questions regarding this notice.

Device

Device Recall Microbiologics KWIKQC SLIDES
  • 모델명 / 제조번호(시리얼번호)
    SL42-10 Lots 4239 to 4243 SL43-10 Lots 4333 to 4337
  • 의료기기 분류등급
    Immunology and Microbiology Devices
  • 의료기기 등급
    1
  • 이식된 장치?
    No
  • 유통
    Worldwide Distribution-USA including the states of CA, IN, MS, NY, OH, PA, and SD, and the countries of AUSTRALIA, AUSTRIA, UNITED ARAB EMIRATES, MALAYSIA, TAIWAN, JAPAN, TURKEY, BELGIUM, COLOMBIA, CANADA, SOUTH AFRICA, and VENEZUELA.
  • 제품 설명
    Microbiologics KWIK-QC SLIDES ( KWIK-QC Acid Fast Stain Slides and KWIK-QC Mycobacterium Slides). || Slide preparations serving as quality control challenges to demonstrate satisfactory performance of staining reagents.
  • Manufacturer
    Microbiologics Inc

Manufacturer

Microbiologics Inc
  • 제조사 주소
    Microbiologics Inc, 200 Cooper Avenue North, Saint Cloud MN 56303-4452
  • 제조사 모회사 (2017)
    Microbiologics Inc
  • Source
    USFDA