Events

Device Recall VITROS Chemistry Products Calibrator Kit 16 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
    60679
  • 사례 위험등급
    Class 2
  • 사례 연번
    Z-0714-2012
  • 사례 시작날짜
    2011-11-10
  • 사례 출판 날짜
    2012-01-11
  • 사례 상황
    Terminated
  • 사례 국가
    United States
  • 사례 종료 날짜
    2018-07-02
  • 사례 출처
    USFDA
  • 사례 출처 URL
    https://www.accessdata.fda.gov/scripts/cdrh/cfdocs/cfres/res.cfm?id=106192
  • 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
    System, test, rheumatoid factor - Product Code DHR
  • 원인
    Ortho clinical diagnostics is recalling lot 1630 of vitros¿ calibrator kit 16 because it will not likely meet its specified 12 months of stability.
  • 조치
    A letter was sent to customers via overnight delivery on 11/10/2011. The letter informed customers they should discontinue using and discard all remaining VITROS Calibrator Kit 16, Lot 1630; Complete and return the attached Confirmation of Receipt form upon receipt of the notification. Once the fax reply is received, the firm will begin the replacement order process; forward the notification to all departments and areas that use the VITROS Calibrator Kit 16, Lot 1630; and post the notification by each VITROS Chemistry or Integrated System in your facility that uses the VITROS Calibrator Kit 16, Lot 1630 or with VITROS user documentation.

Device

Device Recall VITROS Chemistry Products Calibrator Kit 16
  • 모델명 / 제조번호(시리얼번호)
    Lot 1630
  • 의료기기 분류등급
    Immunology and Microbiology Devices
  • 의료기기 등급
    2
  • 이식된 장치?
    No
  • 유통
    Class II Recall: Worldwide Distribution - USA (Nationwide) and the countries of Brazil, Canada, Chile, China, Colombia, England, France, Mexico, Panama, Singapore, Spain, Venezuela.
  • 제품 설명
    VITROS Chemistry Products Calibrator Kit 16, REF 680 1700, 5x1 mL --- Ortho-Clinical Diagnostics, Rochester, NY USA -- Ortho-Clinical Diagnostics High Wycomber, UK. VITROS Chemistry Products Calibrator Kit 16 is used in conjunction with VITROS Chemistry Products FS Calibrator 1 to calibrate the VITROS 5,1 FS Chemistry System, the VITROS 4600 Chemistry System and the VITROS 5600 Integrated System for the quantitative measurement of rheumatoid factor (RF).
  • Manufacturer
    Ortho-Clinical Diagnostics

Manufacturer

Ortho-Clinical Diagnostics
  • 제조사 주소
    Ortho-Clinical Diagnostics, 100 Indigo Creek Drive, Rochester NY 14626
  • Source
    USFDA