Events

Vitros Immunodiagnostic Products CEA REAGENT PACK, Lot 750, REF 192 0115, 100 coated wells per pack. Firm on the label: Ortho-Clinical Diagnostics, Amersham, UK. 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
    27915
  • 사례 위험등급
    Class 3
  • 사례 연번
    Z-0299-04
  • 사례 시작날짜
    2003-12-03
  • 사례 출판 날짜
    2004-01-06
  • 사례 상황
    Terminated
  • 사례 국가
    United States
  • 사례 종료 날짜
    2004-02-20
  • 사례 출처
    USFDA
  • 사례 출처 URL
    https://www.accessdata.fda.gov/scripts/cdrh/cfdocs/cfres/res.cfm?id=30737
  • 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, Carcinoembryonic Antigen - Product Code DHX
  • 원인
    Reagent packs may contain wells that produce a low light signal that could result in calibration failures or negatively biased results.
  • 조치
    U.S. customers notified via FED EX letter sent on 12/3/03. Letter includes modified QC procedures to use until replacement product is issued. Foreign affiliates notified via e-mail on 12/3/03 with instructions to notify customers.

Device

Vitros Immunodiagnostic Products CEA REAGENT PACK, Lot 750, REF 192 0115, 100 coated wells per pa...
  • 모델명 / 제조번호(시리얼번호)
    Lot #750, Exp. 14 January 2004
  • 의료기기 분류등급
    Immunology and Microbiology Devices
  • 의료기기 등급
    2
  • 이식된 장치?
    No
  • 유통
    154 reagent packs shipped to consignees in the U.S. 370 reagent packs shipped to Ortho/J&J; International Affiliates for further distribution to foreign users. Foreign consignees are located in Argentina, Australia, Belgium, Brazil, Chile, China, France, Germany, India, Italy, Japan, Mexico, Panama, Poland, Portugal, Puerto Rico, Singapore, Spain, United Kingdom, and Venezuela.
  • 제품 설명
    Vitros Immunodiagnostic Products CEA REAGENT PACK, Lot 750, REF 192 0115, 100 coated wells per pack. Firm on the label: Ortho-Clinical Diagnostics, Amersham, UK.
  • Manufacturer
    Ortho-Clinical Diagnostics

Manufacturer

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