Events

Device Recall LIGHT DIAGNOSTICS SimulFluor Flu A/Flu B DFA Kit 의 리콜

U.S. Food and Drug Administration에 따르면, 해당 리콜 는 United States 에서 Millipore Corporation 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
    50511
  • 사례 위험등급
    Class 2
  • 사례 연번
    Z-0953-2009
  • 사례 시작날짜
    2008-11-24
  • 사례 출판 날짜
    2009-03-06
  • 사례 상황
    Terminated
  • 사례 국가
    United States
  • 사례 종료 날짜
    2012-08-10
  • 사례 출처
    USFDA
  • 사례 출처 URL
    https://www.accessdata.fda.gov/scripts/cdrh/cfdocs/cfres/res.cfm?id=75564
  • 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
    SimulFluor Flu A/Flu B Immunofluorescence Assay - Product Code GNW
  • 원인
    Certain lots of simulfluor flu a / flu b reagent may cross-react with respiratory synctial virus. the continued use of simulfluor flu a / flu b reagent catalog #5250 may lead to a potential misdiagnosis of influenza b.
  • 조치
    Millipore is performing a voluntary recall by notifying customers and distributors by telephone on November 24, 2008. In addition, an Urgent: Medical Device Recall notification letter with the same date was sent via certified mail. Customers were advised to examine their stock immediately and discontinue the use of the specified lots. Customers were instructed to complete the enclosed Effective Check Survey confirming disposal of defective lots and return this form to Millipore's Regulatory Department. Customer service is to be contacted at 1-800-437-7500 for replacement product. Millipore Corporation will issue credit or replace the recalled lots that customers currently have in inventory.

Device

Device Recall LIGHT DIAGNOSTICS SimulFluor Flu A/Flu B DFA Kit
  • 모델명 / 제조번호(시리얼번호)
    Lot Numbers: JBC1531415, TR1480748, and TR1501924.
  • 의료기기 분류등급
    Immunology and Microbiology Devices
  • 의료기기 등급
    1
  • 이식된 장치?
    No
  • 유통
    Worldwide Distribution -- USA including states of AL, CA, CO, CT, FL, ID, IL, KS, MA, MI, MS, NM, NY, OH, OK, OR, PA, SD, TX, UT, VA, VT, WA, WV, and WI and countries of Canada, Mexico, Italy, Belgium,Germany, France, Spain, and United Kingdom.
  • 제품 설명
    LIGHT DIAGNOSTICS SimulFluor Flu A/Flu B DFA Kit || Immunofluorescence Assay || Cat. No. 3121 || FOR IN VITRO DIAGNOSTIC USE || Authorized Representative: || Millipore (UK) Ltd. || Fleming Road, || Kirkton Campus || Livingston || EH54 7BN || UK. || Tel +44 1506 404000 || Fax +44 1506 404073 || MILLIPORE || 28820 Single Oak Drive Temecula, CA 92590 " USA & Canada || Phone: +1(800) 437-7500 " Fax: +1 (951) 676-9209. || The kit consists of Catalog #5250 Simulfluor Flu A/B; Catalog #5010 Flu A/B Control Slide; Catalog #5013 Mounting Fluid; Catalog #5037 Tween 20/Sodium Azide, 100X; Catalog #5087 PBS Packet
  • Manufacturer
    Millipore Corporation

Manufacturer

Millipore Corporation
  • 제조사 주소
    Millipore Corporation, 28820 Single Oak Dr, Temecula CA 92590-3607
  • 제조사 모회사 (2017)
    Millipore Corporation
  • Source
    USFDA