Events

Selectra ProS and ProM systems 의 리콜

U.S. Food and Drug Administration에 따르면, 해당 리콜 는 United States 에서 ELITech Clinical Systems SAS 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
    72322
  • 사례 위험등급
    Class 2
  • 사례 연번
    Z-0216-2016
  • 사례 시작날짜
    2015-09-22
  • 사례 출판 날짜
    2015-11-05
  • 사례 상황
    Terminated
  • 사례 국가
    United States
  • 사례 종료 날짜
    2016-03-04
  • 사례 출처
    USFDA
  • 사례 출처 URL
    https://www.accessdata.fda.gov/scripts/cdrh/cfdocs/cfres/res.cfm?id=140618
  • 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
    Glucose oxidase, glucose - Product Code CGA
  • 원인
    Elitech clinical systems reagents based on trinder reaction used on the selectra pros and prom systems are recalled due to potential drug interference. no complaints were received.
  • 조치
    The firm sent recall letters or Technical Bulletins to US consignees on 9/22/15 via registered mail. Technical Bulletin #1022 (for EON 100 users) Technical Bulletin #2008 (for EON 300 users) Technical Bulletin #5064 (for ENVOY users) Technical Bulletin #3009 (for Selectra users) ELITechGroup is not requesting return of the affected product. The method sheets and package inserts will be updated with the new interference claims. When available, the revised labeling will be provided to the customer for customer's use until the new IFU is included in the product packaging. Consignees are requested to return the Confirmation of Receipt form back to the firm by FAX to 401-642-9001 or send email to customercare@elitechgroup.com or send via US Post: Vital Diagnostics, 27 Wellington Rd., Lincoln, Rl. If you have any questions, please contact Vital Diagnostics Technical Support at 1-800-345-2822 or 855-ELITECH

Device

Selectra ProS and ProM systems
  • 모델명 / 제조번호(시리얼번호)
    all lots
  • 의료기기 분류등급
    Clinical Chemistry and Clinical Toxicology Devices
  • 의료기기 등급
    2
  • 이식된 장치?
    No
  • 유통
    US Nationwide Distribution
  • 제품 설명
    ELITech Clinical Systems reagents used on the Selectra ProS and ProM systems that utilize the Trinder Reaction method. || The following product reference numbers and names: || GPSL-025O: Glucose PAP SL || AUML-0250: URIC ACID MONO SL || CHSL-0250: CHOLESTEROL SL, || TGML-0250: TRIGLYCERIDES SL, || CRSL-0250: CREATININE PAP SL || HDLL-0230: CHOLESTEROL HDL SL 2G || LDLL-0230: CHOLESTEROL LDL SL 2G
  • Manufacturer
    ELITech Clinical Systems SAS

Manufacturer

ELITech Clinical Systems SAS
  • 제조사 주소
    ELITech Clinical Systems SAS, Zone lndustrielle, SEES France
  • Source
    USFDA