Events

Device Recall RambaChrom KPC M/N 11500 의 리콜

U.S. Food and Drug Administration에 따르면, 해당 리콜 는 United States 에서 Gibson Laboratories 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
    54184
  • 사례 위험등급
    Class 2
  • 사례 연번
    Z-0827-2010
  • 사례 시작날짜
    2009-12-17
  • 사례 출판 날짜
    2010-02-24
  • 사례 상황
    Terminated
  • 사례 국가
    United States
  • 사례 종료 날짜
    2012-09-21
  • 사례 출처
    USFDA
  • 사례 출처 URL
    https://www.accessdata.fda.gov/scripts/cdrh/cfdocs/cfres/res.cfm?id=87782
  • 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
    Culture medium for antimicrobial susceptibility tests - Product Code JSO
  • 원인
    Discrepancies between the product package label and technical insert are conflicting and may be misleading to user. the technical insert included the statement for in vitro diagnostic use. the product insert should have indicated for research use only instead of for in vitro diagnostic use.
  • 조치
    On 12/10/2009 the firm sent letters to their customers notifying them of the problem and instructing them to replace insert with a new one. They were also instructed to complete and return a "Recall Response Form."

Device

Device Recall RambaChrom KPC M/N 11500
  • 모델명 / 제조번호(시리얼번호)
    Lot# 8273017 Exp. Date 11/18/2008; Lot# 8357002 Exp. Date 2/9/2009; Lot# 9099062 Exp. Date 5/28/2009; Lot# 9121097 Exp. Date 6/19/2009; Lot# 9132038 Exp. Date 6/30/2009; Lot# 9134085 Exp. Date 7/2/2009; Lot# 9139025 Exp. Date 7/7/2009; Lot# 9166026 Exp. Date 8/3/2009; Lot# 9177131 Exp. Date 8/14/2009; Lot# 9194004 Exp. Date 8/31/2009; Lot# 9212080 Exp. Date 9/18/2009; Lot# 9222002 Exp. Date 9/28/2009; Lot# 9232053 Exp. Date 10/8/2009; Lot# 9275097 Exp. Date 11/20/2009; Lot# 9288050 Exp. Date 12/3/2009; Lot# 9306001 Exp. Date 12/21/2009; Lot# 9322047 Exp. Date 1/6/2010
  • 의료기기 분류등급
    Immunology and Microbiology Devices
  • 의료기기 등급
    2
  • 이식된 장치?
    No
  • 유통
    Distribution of the product was limited to AL, FL, IL, KY, MA, MI, MO, NY, OH, PA, & VA and one customer in France.
  • 제품 설명
    RambaChrom KPC M/N 11500. RambaCHROM KPC is for detection of gram negative bacteria with a reduced susceptibility to most of the carbapenem agents.
  • Manufacturer
    Gibson Laboratories Inc

Manufacturer

Gibson Laboratories Inc
  • 제조사 주소
    Gibson Laboratories Inc, 1040 Manchester St, Lexington KY 40508-2422
  • 제조사 모회사 (2017)
    Gibson Laboratories Llc
  • Source
    USFDA