Events

Device Recall Shigella Antiserum Poly Group B 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
    46323
  • 사례 위험등급
    Class 2
  • 사례 연번
    Z-1528-2008
  • 사례 시작날짜
    2007-11-30
  • 사례 출판 날짜
    2008-08-16
  • 사례 상황
    Terminated
  • 사례 국가
    United States
  • 사례 종료 날짜
    2008-11-12
  • 사례 출처
    USFDA
  • 사례 출처 URL
    https://www.accessdata.fda.gov/scripts/cdrh/cfdocs/cfres/res.cfm?id=68191
  • 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
    Antisera, shigella - Product Code GNB
  • 원인
    In vitro diagnostic test reagent for identification of shigella bacteria in patient samples may cause false negative results.
  • 조치
    The recalling firm notified distributors by faxed letter flagged as "Urgent Product Recall" and e-mail on 11/30/07. Distributors were instructed to cease distribution and discard identified product and return a list of end user consignees for direct notification by Becton Dickinson. End users were notified by letter flagged as an "Urgent Product Recall" on 11/30/06 through 12/06/07. Customers were instructed to discontinue and discard affected product for replacement. The notification included a reply form that BD requested users to fax back with the quantity of replacement vials needed.

Device

Device Recall Shigella Antiserum Poly Group B
  • 모델명 / 제조번호(시리얼번호)
    Lot 6009070 Exp November 03, 2011
  • 의료기기 분류등급
    Immunology and Microbiology Devices
  • 의료기기 등급
    2
  • 이식된 장치?
    No
  • 유통
    Worldwide Distribution
  • 제품 설명
    Lee Laboratories brand Shigella Antiserum Poly Group B, catalog number 210722, 10 mL vials and labeled in part ***Lee Laboratories, Inc Grayson, Georgia 30017*** || Used for the identification of Shigella species by the slide agglutination test
  • Manufacturer
    Becton Dickinson & Co.

Manufacturer

Becton Dickinson & Co.