Events

Device Recall BD GeneOhm Cdiff 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-2319-2012
  • 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=110805
  • 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
    Reagents, clostridium difficile toxin - Product Code LLH
  • 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 Cdiff Assay
  • 모델명 / 제조번호(시리얼번호)
    Lot/ Exp. 08T11250 2012-07-06
  • 의료기기 분류등급
    Immunology and Microbiology Devices
  • 의료기기 등급
    1
  • 이식된 장치?
    No
  • 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 Cdiff Assay , Catalog # 441401, 200 box tests 2-3 labeled in part***GeneOhm Sciences Canada, Inc., 2555 boul, du Parc-Technologique, Quebec, QC, Canada G1P 4S5*** || BD GeneOhm Cdiff Assay is a qualitative in vitro diagnostic test for the direct detection of C. difficile toxin gene (tcdB) in human liquid or soft stool specimens from patients suspected of having Clostridium difficile-associated disease (CDAD). The test, based on real-time PCR, is intended for use as an aid in diagnosis of CDAD. The test is performed directly on the specimen, utilizing polymerase chain reaction (PCR) for the amplification of specific targets and fluorogenic target-specific hybridization probes for the detection of the amplified DNA.
  • 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