Events

Device Recall Vitros Universal Wash Reagent 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
    25394
  • 사례 위험등급
    Class 3
  • 사례 연번
    Z-0558-03
  • 사례 시작날짜
    2003-01-10
  • 사례 출판 날짜
    2003-02-21
  • 사례 상황
    Terminated
  • 사례 국가
    United States
  • 사례 종료 날짜
    2003-06-03
  • 사례 출처
    USFDA
  • 사례 출처 URL
    https://www.accessdata.fda.gov/scripts/cdrh/cfdocs/cfres/res.cfm?id=25733
  • 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 and the Product Classification were added by ICIJ.
    The parent company information is based on 2017 public records. The device classification information comes from FDA’s Product Classification by Review Panel data.
  • 데이터 추가 비고
  • 원인
    Label printing irregularities on cartons and/or bottles.
  • 조치
    Letters dated 1/10/03 sent U.S. Mail instructing customers to examine inventory and discard bottles or cartons with missing or illegible print.

Device

Device Recall Vitros Universal Wash Reagent
  • 모델명 / 제조번호(시리얼번호)
    Lot 5003, Exp. 12 September 2003
  • 의료기기 분류등급
    Clinical Chemistry and Clinical Toxicology Devices
  • 유통
    Product was shipped to medical facilities nationwide. There were 6 federal government consignees shipped product under government contract #V797-6565A. No product was shipped outside the U.S.
  • 제품 설명
    Vitros Immunodiagnostic Products *** UNIVERSAL WASH REAGENT *** for in vitro diagnostic use only. The product is sold in cartons containing 2 bottles (5 liters each). CAT 838 9793
  • Manufacturer
    Ortho-Clinical Diagnostics

Manufacturer

Ortho-Clinical Diagnostics
  • 제조사 주소
    Ortho-Clinical Diagnostics, 100 Indigo Creek Drive, Rochester NY 14650-0881
  • Source
    USFDA