Events

Device Recall VITROS Immunodiagnostic Products NTpro BNP Reagent Pack 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
    76665
  • 사례 위험등급
    Class 2
  • 사례 연번
    Z-1765-2017
  • 사례 시작날짜
    2017-03-07
  • 사례 상황
    Open, Classified
  • 사례 국가
    United States
  • 사례 출처
    USFDA
  • 사례 출처 URL
    https://www.accessdata.fda.gov/scripts/cdrh/cfdocs/cfres/res.cfm?id=153781
  • 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
    Test,natriuretic peptide - Product Code NBC
  • 원인
    Increased frequency of calibration failures for vitros immunodiagnostic products nt-probnp reagent lots 1568, 1570, 1580 and 1590, due to background signals for these affected nt-probnp lots that have been increasing with time since release testing, resulting in higher than expected vitros immunodiagnostic products nt-probnp level 1 calibrator signals produced, leading to calibration failures.
  • 조치
    On 3/7/2017, IMPORTANT PRODUCT CORRECTION NOTIFICATION letter (Ref. CL2017-048) was sent via FedEx overnight courier and/ or ORTHO PLUS e-Communications and/ or US Postal Service Priority Mail (for PO Boxes only) to all customers and distributors who were shipped VITROS NT-proBNP Reagent Packs, Lots 1570, 1580 and/or 1590 to inform them of the issue and provided further instructions.

Device

Device Recall VITROS Immunodiagnostic Products NTpro BNP Reagent Pack
  • 모델명 / 제조번호(시리얼번호)
    Lot 1570 (expiry 22 March 2017),  Lot 1580 (expiry 13 April 2017),  Lot 1590 (expiry 27 April 2017)
  • 의료기기 분류등급
    Clinical Chemistry and Clinical Toxicology Devices
  • 의료기기 등급
    2
  • 이식된 장치?
    No
  • 유통
    Worldwide: United States, Puerto Rico, Bermuda, Australia, Brazil, Canada, Chile, China, Colombia, England, France, Germany, India, Italy, Japan, Mexico, Panama, Poland, Singapore, Spain, and Venezuela.
  • 제품 설명
    VITROS Immunodiagnostic Products NT-pro BNP Reagent Pack, REF/Catalog 680 2156, IVD --- Ortho-Clinical Diagnostics Pencoed, Bridgend CF35 5PZ, UK
  • Manufacturer
    ORTHO-CLINICAL DIAGNOSTICS

Manufacturer

ORTHO-CLINICAL DIAGNOSTICS
  • 제조사 주소
    ORTHO-CLINICAL DIAGNOSTICS, FELINDRE MEADOWS, Bridgend United Kingdom
  • 제조사 모회사 (2017)
    The Carlyle Group LP
  • Source
    USFDA