Events

Device Recall Pointe Scientific Creatinine 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
    71974
  • 사례 위험등급
    Class 3
  • 사례 연번
    Z-2773-2015
  • 사례 시작날짜
    2014-12-12
  • 사례 출판 날짜
    2015-09-16
  • 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=139476
  • 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
    Alkaline picrate, colorimetry, creatinine - Product Code CGX
  • 원인
    Creatinine kit c7539-150 contains creatinine reagent r1 that is labeled as creatinine reagent r2 (30ml) and reagent r2 vial is labeled as r1 (120ml). with manual procedure, no result will be reported as the control will be out of specifications.
  • 조치
    On 12/12/2014, Field Correction Notice notifications were sent to the affected distributors via electronic 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 Pointe Scientifics Technical Service Department at 1-800-757-5313.

Device

Device Recall Pointe Scientific Creatinine Reagent
  • 모델명 / 제조번호(시리얼번호)
    C7539-150 Lot: 406201 Batch: 279 Expiration date: 2016-03
  • 의료기기 분류등급
    Clinical Chemistry and Clinical Toxicology Devices
  • 의료기기 등급
    2
  • 이식된 장치?
    No
  • 유통
    Worldwide distribution. US nationwide, Singapore, Kenya, Bolivia, Mexico, Greece, Guyana, and Philippines.
  • 제품 설명
    Pointe Scientific Creatinine Reagent || Catalog number C7539-150 || in vitro diagnostic || C7539-150 kit includes one R1 and one R2 bottle. || R1: HDPE plastic bottle. 120 ml fill. || R2: HDPE plastic bottle. 90 ml fill.
  • 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