Events

Device Recall Kit Meter EZCHEM 의 리콜

U.S. Food and Drug Administration에 따르면, 해당 리콜 는 United States 에서 Nova Biomedical 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
    45815
  • 사례 위험등급
    Class 2
  • 사례 연번
    Z-0724-2008
  • 사례 시작날짜
    2007-11-02
  • 사례 출판 날짜
    2008-02-16
  • 사례 상황
    Terminated
  • 사례 국가
    United States
  • 사례 종료 날짜
    2008-12-09
  • 사례 출처
    USFDA
  • 사례 출처 URL
    https://www.accessdata.fda.gov/scripts/cdrh/cfdocs/cfres/res.cfm?id=66206
  • 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
    Ion Based Enzymatic Electrode (Creatinine) - Product Code CGL
  • 원인
    Incorrect results - creatinine results were lower than the laboratory reference method.
  • 조치
    Nova Biomedical issued an Urgent: Medical Device Recall notification letter to consignees dated November 19, 2007. The letter addressed the issues with the product(s) and requested that if users had any remaining stock that it must be returned. The firm also provided a Customer Response form to be returned. Questions concerning this recall will be addressed by Gina Vogelsberg at 1-800-544-4624 or by email at gvogelsberg@ezem.com.

Device

Device Recall Kit Meter EZCHEM
  • 모델명 / 제조번호(시리얼번호)
    Serial Numbers: 39000207226 39000207229 39000207256 39000207270 39000307226 39000307229 39000307256 39000307270 39000407229 39000407270 39000507226 39000507229 39000507270 39000607229 39000607270 39000707229 39000707270 39000807226 39000807229 39000907270 39001007229 39001007256 39001007270 39001107229 39001107256 39001107270 39001207256 39001207270 39001307256 39001307270 39001407256 39001407270 39001507256 39001507270 39001607256 39001607270 39001707256 39001707270 39001807256 39001807270 39001907256 39001907270 39002007256 39002007270 39002107256 39002107270 39002207256 39002207270 39002307256 39002307270 39002407256 39002407270 39002507256 39002507270 39002607256 39002707256 39002907256 39003007256 39003107256 39003207256 39003307256 39006207249 39006307249 39006407249 39006507249 39006607249 39006607263 39006707249 39006707263 39006807249 39006807263 39006907249 39006907263 39007007263 39007107263 39007207263 39007307249 39007407249 39007507249 39007807249 39007907249 39008007249 39008107249 39008207249 39008307249 39008407249 39008507249 39008607249 39009607263 39009707263 39009807263 39009907263 39010007263 39010507275 39010607275 39010707275 39010807275 39010907275 39011007275 39011107275 39011207275 39011507275 39011607275 39011707275 39011807275 39011907275 39012007275 39012107275 39012307275 39012807275 39012907275 39013007275 39013207275 39013307275 39013407275 39013507275 39013607275 39013707275 39013807275 39013907275 39014107275 39014207275 39014307275 39014407275 39014507275 39014607275 39014707275 39014807275 39014907275 39015007275 39015107275 39015207275 39015307275
  • 의료기기 분류등급
    Clinical Chemistry and Clinical Toxicology Devices
  • 의료기기 등급
    2
  • 이식된 장치?
    No
  • 유통
    Nationwide Distribution, including the state of NY
  • 제품 설명
    Nova - EZ CHEM Creatinine Meter: SRS Versions 5.1 and 5.2 || P/N 9600, Nova Biomedical, Waltham, MA 02454
  • Manufacturer
    Nova Biomedical Corporation

Manufacturer

Nova Biomedical Corporation
  • 제조사 주소
    Nova Biomedical Corporation, 200 Prospect St, Waltham MA 02453
  • 제조사 모회사 (2017)
    Nova Biomedical Corporation
  • Source
    USFDA