Events

Device Recall KWIKQC Gram Stain 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
    61998
  • 사례 위험등급
    Class 2
  • 사례 연번
    Z-1936-2012
  • 사례 시작날짜
    2012-05-29
  • 사례 출판 날짜
    2012-07-03
  • 사례 상황
    Terminated
  • 사례 국가
    United States
  • 사례 종료 날짜
    2013-01-08
  • 사례 출처
    USFDA
  • 사례 출처 URL
    https://www.accessdata.fda.gov/scripts/cdrh/cfdocs/cfres/res.cfm?id=109669
  • 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 is recalling a number of lots of kwik-qc gram stain slides. this product gram negative control organism (e.Coli) is 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 potentially lead to misdiagnosis and improper treatment of a patient.
  • 조치
    Microbiologics sent an "URGENT MEDICAL DEVICE RECALL" letter dated May 30, 2012 to all affected customers. The letter identifies the product, problem, and actions to be taken by the customers. The letter instructs customers not to use or distribute the affected product and to quarantine and return to the firm any remaining product. A Customer Response Form was attached for customers to complete and return to the firm. Contact Customer Service at 320-229-7057 for questions regarding this recall.

Device

Device Recall KWIKQC Gram Stain Slides
  • 모델명 / 제조번호(시리얼번호)
    0353 - 0355, 0357 - 0363
  • 의료기기 분류등급
    Immunology and Microbiology Devices
  • 의료기기 등급
    1
  • 이식된 장치?
    No
  • 유통
    Worldwide Distribution-USA (nationwide) including the states of AZ, CA, CO, FL, GA, IL, IA, KY, ME, MA, MI, MN, MS, NJ, NM, NY, PA, PR, SC, TX, VT, and VA. and the countries of SWITZERLAND, ITALY, ISRAEL, IRELAND, COLOMBIA, SWEDEN, INDIA, SINGAPORE, SERBIA, SAUDI ARABIA, CANADA, TAIWAN, SOUTH AFRICA, FRANCE, BRAZIL, MALTA, MACEDONIA, MALAYSIA, FINLAND, ECUADOR, VENEZUELA, REPUBLIC OF KOREA, NETHERLANDS, PERU, UNITED ARAB EMERITES, TURKEY, POLAND, and LEBANON.
  • 제품 설명
    Microbiologics 217 Osseo Avenue North, St. Cloud, MN 56303, Gram Stain Control Slides, SLO3-10, ATCC Licensed Derivative, MediMart Europe, 11 rue Emile, Zola B.P. 2332, 38933 Grenoble Cedex 2 France. || They are microscope slide preparations contains specific organisms populations of known and predictable characteristics. These slide support formal quality assurance programs by serving as quality control challenges to demonstrate and document satisfactory performance of staining regents and methods used in staining procedures and to document personnel's ability to perform the procedure and to properly interpret the microscopic test results.
  • Manufacturer
    Microbiologics Inc

Manufacturer

Microbiologics Inc
  • 제조사 주소
    Microbiologics Inc, 217 Osseo Ave N, Saint Cloud MN 56303-4452
  • 제조사 모회사 (2017)
    Microbiologics Inc
  • Source
    USFDA