Events

VITROS CRP Slides: (1) Cat # 192 6740, 250 slides per box, and (2) Cat # 809 7990, 90 slides per box. Firm on the label: Ortho-Clinical Diagnostics, Inc., Rochester, NY 14626. The CRP Slides are for use on the Vitros 250/250AT and/or Vitros 950/950AT Clinical Chemistry Systems. For in vitro diagnostic use. Vitros CRP slides quantitatively measure C-reactive protein concentration in serum and plasma. 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
    29887
  • 사례 위험등급
    Class 3
  • 사례 연번
    Z-1473-04
  • 사례 시작날짜
    2004-07-28
  • 사례 출판 날짜
    2004-09-18
  • 사례 상황
    Terminated
  • 사례 국가
    United States
  • 사례 종료 날짜
    2005-06-09
  • 사례 출처
    USFDA
  • 사례 출처 URL
    https://www.accessdata.fda.gov/scripts/cdrh/cfdocs/cfres/res.cfm?id=34728
  • 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
    C-Reactive Protein, Antigen, Antiserum, And Control - Product Code DCK
  • 원인
    The immuno-rate (ir) wash detection algorithm may result in inappropriate wash detections.
  • 조치
    Letters dated 7/28/2004. Distributors instructed to destroy product. Users instructed to use revised IR wash tolerance values (provided with letter). A Calibration Diskette, Data Release Version 5384 will also be provided to end users.

Device

VITROS CRP Slides: (1) Cat # 192 6740, 250 slides per box, and (2) Cat # 809 7990, 90 slides per ...
  • 모델명 / 제조번호(시리얼번호)
    Coatings 401 thru 409 (Generations 92, 93, 94, 99, 01, 02, 03, 04, and 05)
  • 의료기기 분류등급
    Immunology and Microbiology Devices
  • 의료기기 등급
    2
  • 이식된 장치?
    No
  • 유통
    DOMESTIC distribution (nationwide): Product shipped to 6 distributors, 140 hospitals, and 6 U.S. government accounts. FOREIGN distribution: Product shipped to 22 Ortho-Clinical/J&J; affiliates in Argentina, Australia, Brazil, Canada, Chile, China, Colombia, Peru, Ecuador, India, Japan, Mexico, Puerto Rico, Panama, Singapore, Venezuela, England, France, Germany, Italy and Spain. The foreign affiliates further distributed product.
  • 제품 설명
    VITROS CRP Slides: (1) Cat # 192 6740, 250 slides per box, and (2) Cat # 809 7990, 90 slides per box. Firm on the label: Ortho-Clinical Diagnostics, Inc., Rochester, NY 14626. The CRP Slides are for use on the Vitros 250/250AT and/or Vitros 950/950AT Clinical Chemistry Systems. For in vitro diagnostic use. Vitros CRP slides quantitatively measure C-reactive protein concentration in serum and plasma.
  • 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