Events

Device Recall BD GeneOhm VanR Assay 의 리콜

U.S. Food and Drug Administration에 따르면, 해당 리콜 는 United States 에서 Becton Dickinson & Co. 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
    62505
  • 사례 위험등급
    Class 2
  • 사례 연번
    Z-2320-2012
  • 사례 시작날짜
    2012-05-22
  • 사례 출판 날짜
    2012-09-06
  • 사례 상황
    Terminated
  • 사례 국가
    United States
  • 사례 종료 날짜
    2012-11-02
  • 사례 출처
    USFDA
  • 사례 출처 URL
    https://www.accessdata.fda.gov/scripts/cdrh/cfdocs/cfres/res.cfm?id=110881
  • 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
  • 원인
    Leakage in cepheid smartcycler reaction tubes.
  • 조치
    BD Diagnostic Systems issued an Urgent Product Recall letter via UPS overnight delivery on May 22, 2012. The letter identified the product, the problem, and the action to be taken by the customer. Customers were instructed to take the following actions: Discontinue use and discard any affected product. BD would send replacement tubes for the discarded material. Complete the attached form whether or not they have any inventory remaining so that the firm may acknowledge their receipt of the notification. Fax the form to: Attention: Regulatory Compliance FAX: 410-316-4258 Email: RegulatoryComplianceFax@bd.com If further assistance is needed, customers should contact BD Technical Services Department at 1-800-838-8663. For questions regarding this recall call 410-316-4054.

Device

Device Recall BD GeneOhm VanR Assay
  • 모델명 / 제조번호(시리얼번호)
    Lot/ Exp. 05T11042 2012-04-30 (ONLY SOLD IN EUROPE)
  • 유통
    Nationwide Distribution including CA, DE, FL, GA, IL, IN, KS, KY, ME, MT, NC, NJ, NM, NY, OH, OK, PA, SC, TX, VA, WA, WI, and WV.
  • 제품 설명
    BD GeneOhm VanR Assay , Catalog # 441250, 5 box tests labeled in part***GeneOhm Sciences Canada, Inc., 2555 boul, du Parc-Technologique, Quebec, QC, Canada G1P 4S5***. || The BD GeneOhm VanR Assay is a qualitative in vitro test for the rapid detection of vancomycin-resistance (vanA and vanB) genes directly from perianal or rectal swabs. The BD GeneOhm VanR Assay detects the presence of the vanA and vanB genes that can be associated with vancomycin-resistant enterococci (VRE). The assay is performed on an automated real-time PCR instrument with perianal or rectal swabs from individuals at risk for VRE colonization. The BD GeneOhm VanR Assay can be used as an aid to identify, prevent and control vancomycin-resistant colonization in healthcare settings. The BD GeneOhm VanR Assay is not intended to diagnose VRE infections nor to guide or monitor treatment for VRE infections. Concomitant cultures are necessary to recover organisms for epidemiological typing, susceptibility testing and for further confirmatory identification.
  • Manufacturer
    Becton Dickinson & Co.

Manufacturer

Becton Dickinson & Co.
  • 제조사 주소
    Becton Dickinson & Co., BD Diagnostic Systems, 7 Loveton Circle, Sparks MD 21152-0999
  • 제조사 모회사 (2017)
    Becton, Dickinson and Company
  • Source
    USFDA