Events

Exact Sciences Sample Mixer 2 의 리콜

U.S. Food and Drug Administration에 따르면, 해당 리콜 는 United States 에서 Exact Sciences Corporation 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
    77260
  • 사례 위험등급
    Class 2
  • 사례 연번
    Z-2219-2017
  • 사례 시작날짜
    2017-04-28
  • 사례 출판 날짜
    2017-06-01
  • 사례 상황
    Terminated
  • 사례 국가
    United States
  • 사례 종료 날짜
    2017-08-11
  • 사례 출처
    USFDA
  • 사례 출처 URL
    https://www.accessdata.fda.gov/scripts/cdrh/cfdocs/cfres/res.cfm?id=155572
  • 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, colorectal neoplasia, DNA methylation and hemoglobin detection - Product Code PHP
  • 원인
    Exact sciences is correcting all sample mixer v2 upgrade units because of incidents of sample mixer door damage, which has occurred when the sample holder opens during a run and the sample holder lid makes contact with the sample mixer door.
  • 조치
    Exact Sciences sent an Urgent Medical Device Correction letter dated April 28, 2017, via email to all affected consignees. The letter identified affected products and explained the issue. Exact Sciences personnel will correct each unit. Questions can be directed to 608-210-5183.

Device

Exact Sciences Sample Mixer 2
  • 모델명 / 제조번호(시리얼번호)
    Equipment ID / Serial Number:  MIX-0051 / MX00002051,  MIX-0052 / MX00002032, MIX-0053 / MX00002028, MIX-0054 / MX00002052, MIX-0055 / MX00002043, MIX-0056 / MX00002040, MIX-0057 / MX00002050, MIX-0058 / MX00002036, MIX-0059 / MX00002027, MIX-0060 / MX00002015, MIX-0061 / MX00002016, MIX-0063 / MX00002039, MIX-0064 / MX00002033, MIX-0065 / MX00002053, MIX-0066 / MX00002014,
  • 의료기기 분류등급
    Hematology and Pathology Devices
  • 의료기기 등급
    3
  • 이식된 장치?
    No
  • 유통
    US to WI only
  • 제품 설명
    Exact Sciences Sample Mixer 2. For In Vitro Diagnostic Use. || The Exact Sciences Sample Mixer 2 is intended for mixing stool samples in a Sample Container as part of pre-analytic sample processing for in vitro diagnostic tests
  • Manufacturer
    Exact Sciences Corporation

Manufacturer

Exact Sciences Corporation
  • 제조사 주소
    Exact Sciences Corporation, 441 Charmany Dr, Madison WI 53719-1234
  • 제조사 모회사 (2017)
    Exact Sciences Corporation
  • Source
    USFDA