Events

BioGenex Super Sensitive LinkLabel IHC Detection System 의 리콜

U.S. Food and Drug Administration에 따르면, 해당 리콜 는 United States 에서 Biogenex Laboratories 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
    36514
  • 사례 위험등급
    Class 3
  • 사례 연번
    Z-0217-2007
  • 사례 시작날짜
    2006-10-03
  • 사례 출판 날짜
    2006-12-08
  • 사례 상황
    Terminated
  • 사례 국가
    United States
  • 사례 종료 날짜
    2007-12-04
  • 사례 출처
    USFDA
  • 사례 출처 URL
    https://www.accessdata.fda.gov/scripts/cdrh/cfdocs/cfres/res.cfm?id=48784
  • 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
    ICH Detection Kit - Product Code NJT
  • 원인
    Mislabeling: the product's "contents section " labeling (outer box) is mislabeled incorrectly printed as '1 x 100 ml alk phos label' which should read '1 x 100 ml hrp label'. a second, smaller label, incorrectly reads "rtu multilink hpr/aec" which should be labeled as "rtu multilink hpr". the reagent vials in the box are correctly labeled.
  • 조치
    The firms provided written notificaiton letter on approximately 10/03/06, which includes a ''reply back form'' which the firm has requested to be sent back to them. The firm has asked distributors to inform their accounts of the correction, in the event that the product has been shipped out to customers.

Device

BioGenex Super Sensitive LinkLabel IHC Detection System
  • 모델명 / 제조번호(시리얼번호)
    Catalog Number QP300-XAK, Lot numbers QP3000905B, QP3000905C, QP3001205B, QP3001005, QP3001205, QP3000206, QP3001205C, QP3000506, QP3000506B, QP3000506C, QP3000606, QP3000706.
  • 의료기기 분류등급
    Hematology and Pathology Devices
  • 의료기기 등급
    1
  • 이식된 장치?
    No
  • 유통
    Worldwide-USA (including VA Medical Center) and Greece, Jordan, France, India, Taiwan, United Kingdom, Turkey, and Italy
  • 제품 설명
    Super Sensitive Link-Label IHC Detection System/Mega Volume, RTU Multi-Link-HRP, REF/Cat. No. QP300-XAK, Kit containing reagent vials, Bio-Genex, San Ramon, CA.
  • Manufacturer
    Biogenex Laboratories

Manufacturer

Biogenex Laboratories
  • 제조사 주소
    Biogenex Laboratories, 4600 Norris Canyon Road, San Ramon CA 94583-1320
  • Source
    USFDA