Events

VITROS Chemistry GENT Reagent REF 680 1711, *** Responsible firm on label: Ortho-Clinical Diagnostics Inc., Rochester, NY 14626. Each box contains 6 packs. Each pack contains liquid reagent for 50 tests. 의 리콜

U.S. Food and Drug Administration에 따르면, 해당 리콜 는 United States 에서 Ortho-Clinical Diagnostics 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
    32801
  • 사례 위험등급
    Class 2
  • 사례 연번
    Z-1460-05
  • 사례 시작날짜
    2005-07-19
  • 사례 출판 날짜
    2005-09-01
  • 사례 상황
    Terminated
  • 사례 국가
    United States
  • 사례 종료 날짜
    2006-03-13
  • 사례 출처
    USFDA
  • 사례 출처 URL
    https://www.accessdata.fda.gov/scripts/cdrh/cfdocs/cfres/res.cfm?id=40842
  • 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
    Enzyme Immunoassay, Gentamicin - Product Code LCD
  • 원인
    Negatively biased results can be observed when the reagent pack has less than 12 tests remaining and has been on the analyzer greater than 24 hours.
  • 조치
    Letters dated 7/19/2005 with instructions to process QC fluid according to the IFU when processing patient samples. When replacement product arrives, instructions are to destroy the remaining inventory of the recalled lots.

Device

VITROS Chemistry GENT Reagent REF 680 1711, *** Responsible firm on label: Ortho-Clinical Diagno...
  • 모델명 / 제조번호(시리얼번호)
    01-5846, Exp. 31 May 2006; 01-6036 Exp 31 October 2006; 01-6239 Exp 31 January 2007
  • 의료기기 분류등급
    Clinical Chemistry and Clinical Toxicology Devices
  • 의료기기 등급
    2
  • 이식된 장치?
    No
  • 유통
    The product was shipped nationwide and to Ortho-Clinical/J&J; affiliates in Australia, Canada, Singapore, England, France, Germany, Italy and Spain.
  • 제품 설명
    VITROS Chemistry GENT Reagent REF 680 1711, *** Responsible firm on label: Ortho-Clinical Diagnostics Inc., Rochester, NY 14626. Each box contains 6 packs. Each pack contains liquid reagent for 50 tests.
  • Manufacturer
    Ortho-Clinical Diagnostics

Manufacturer

Ortho-Clinical Diagnostics
  • 제조사 주소
    Ortho-Clinical Diagnostics, 100 Indigo Creek Dr, Rochester NY 14626-5101
  • 제조사 모회사 (2017)
    The Carlyle Group LP
  • Source
    USFDA