Events

Device Recall Pointe Scientific, Med Test, Pointe Scientific autoHDL Reagent 의 리콜

U.S. Food and Drug Administration에 따르면, 해당 리콜 는 United States 에서 Pointe Scientific, Inc. 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
    71953
  • 사례 위험등급
    Class 3
  • 사례 연번
    Z-2764-2015
  • 사례 시작날짜
    2015-03-13
  • 사례 출판 날짜
    2015-09-14
  • 사례 상황
    Terminated
  • 사례 국가
    United States
  • 사례 종료 날짜
    2015-10-29
  • 사례 출처
    USFDA
  • 사례 출처 URL
    https://www.accessdata.fda.gov/scripts/cdrh/cfdocs/cfres/res.cfm?id=139474
  • 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
    Ldl & vldl precipitation, hdl - Product Code LBR
  • 원인
    Crystals may be observed in the r1 reagent. crystals may be a result of the reagent being frozen during transport. the crystals do not impact product performance.
  • 조치
    Pointe Scientific sent a Field Correction Notice on March 13, 2015, to all affected customers via fax, email, and mail. The recall notification included a description of the reason for the recall, affected product, consignee responsibilities, and instructions for responding to the formal recall notification. Any questions concerning the corrective action may be directed to Technical Service Department at 1-800-757-5313.

Device

Device Recall Pointe Scientific, Med Test, Pointe Scientific autoHDL Reagent
  • 모델명 / 제조번호(시리얼번호)
    Catalog numbers: H7545-R1, 12-H7545-162, H7545-1000, HDL600 Lot number: 430402
  • 의료기기 분류등급
    Clinical Chemistry and Clinical Toxicology Devices
  • 의료기기 등급
    1
  • 이식된 장치?
    No
  • 유통
    Worldwide Distribution - US including MI, FL, CA, TX, CT, PR and Internationally to Canada.
  • 제품 설명
    Pointe Scientific autoHDL Reagent H7545 || H7545-R1 in a bulk cube container or HDPE plastic bottle || H7545-1000 kit includes 1x750 ml of R1 and 1x250 ml of R2 || 12-H7545-162 kit includes 3x40 ml of R1 and 3x14 ml of R2 || HDL600 kit includes 3x40 ml of R1 and 3x14 ml of R2 || Kits: HDPE plastic bottle, PP plastic caps. || Bulk: PE plastic cube containers, PP plastic caps. || Quantitative determination of high density lipoprotein cholesterol in human serum or plasma. In vitro diagnostic use only.
  • Manufacturer
    Pointe Scientific, Inc.

Manufacturer

Pointe Scientific, Inc.
  • 제조사 주소
    Pointe Scientific, Inc., 5449 Research Dr, Canton MI 48188-2261
  • 제조사 모회사 (2017)
    Medtest Holdings Inc
  • Source
    USFDA