Events

CELLSEARCH Circulating Tunor Cell Kit (Epithelial) 의 리콜

U.S. Food and Drug Administration에 따르면, 해당 리콜 는 United States 에서 Menarini Silicon Biosystems 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
    79872
  • 사례 위험등급
    Class 2
  • 사례 연번
    Z-1530-2018
  • 사례 시작날짜
    2018-04-04
  • 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=163784
  • 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, immunomagnetic, circulating cancer cell, enumeration - Product Code NQI
  • 원인
    Unusually high number of total images/unassigned events may require additional time and effort for the operator to review all the images and may cause a delay in reporting the results.
  • 조치
    Menarini silicon biosystems sent an Urgent Medical Device Correction Notification dated April 3, 2018. Required Actions. " Please dispose of any affected product in your current inventory . " Report any previous occurrence of unusually high number of total images I unassigned events in patient samples to Customer Technical Support. " Complete and return the enclosed Confirmation of Receipt form no later than April 20,2018. For further question, please call (215) 830-0777.

Device

CELLSEARCH Circulating Tunor Cell Kit (Epithelial)
  • 모델명 / 제조번호(시리얼번호)
    UDI (01)10888385000012(17)180810(10)S038 (01)10888385000012(17)180810(10) (01)10888385000012(17)180810(10)S038S (01)10888385000012(17)180810(10)S038T (01)10888385000012(17)180810(10)S038U (01)10888385000012(17)180810(10)S038 V  Serial, Batch, Lot # 2038 S038R S038S S038T S038U S038V S038W (0 distributed to the field)
  • 의료기기 분류등급
    Hematology and Pathology Devices
  • 의료기기 등급
    2
  • 이식된 장치?
    No
  • 유통
    Worldwide Distribution - USA (nationwide) and to the countries of : Canada and Italy
  • 제품 설명
    CELLSEARCH¿ CIRCULATING Tumor Cell Kits (IVD) (Product Code 7900001) || CELLSEARCH¿ CIRCULATING Tumor Cell Kit is intended for the enumeration of circulating tumor cells (CTC) of the epithelial origin (CD45-, EpCAM+, cytokeratins 8, 18+, and/or 19+) in whole blood.
  • Manufacturer
    Menarini Silicon Biosystems

Manufacturer

Menarini Silicon Biosystems
  • 제조사 주소
    Menarini Silicon Biosystems, 3401 Masons Mill Rd Ste 100, Huntingdon Valley PA 19006-3574
  • 제조사 모회사 (2017)
    Pharmafin Spa
  • Source
    USFDA