Events

Device Recall Liquid Alkaline Phosphatase (R2) Reagent Set 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
    35496
  • 사례 위험등급
    Class 2
  • 사례 연번
    Z-1390-06
  • 사례 시작날짜
    2006-06-09
  • 사례 출판 날짜
    2006-08-10
  • 사례 상황
    Terminated
  • 사례 국가
    United States
  • 사례 종료 날짜
    2007-11-19
  • 사례 출처
    USFDA
  • 사례 출처 URL
    https://www.accessdata.fda.gov/scripts/cdrh/cfdocs/cfres/res.cfm?id=47225
  • 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
    in vitro diagnostic - Product Code CJE
  • 원인
    The reagent may be contaminated with microorganisms.
  • 조치
    Consignees were notified via recall letter dated 6/9/06 to cease using the product, conduct a recall to the user level, destroy product on hand and to notify the firm via the response form of the amount destroyed for replacement purposes. International consignees were notified via email.

Device

Device Recall Liquid Alkaline Phosphatase (R2) Reagent Set
  • 모델명 / 제조번호(시리얼번호)
    Lots 500701(exp. 7/06), 508001 (exp. 9/06), 513003 (exp. 11/06), 521601 (exp. 2/07), 530101 (exp. 4/07), 534901 (exp. 6/07), 603301 (exp. 8/07) and 607601 (exp. 9/07).
  • 의료기기 분류등급
    Clinical Chemistry and Clinical Toxicology Devices
  • 의료기기 등급
    2
  • 이식된 장치?
    No
  • 유통
    Worldwide, including USA, Bolivia, Cameroon, China, Cyprus, Egypt, Greece, India, Israel, Kenya, Korea, Lebanon, Malaysia, Mexico, Nepal, Nicaragua, Nigeria, Pakistan, Panama, Peru, Philippines, Poland, Russia, Singapore, Thailand, Trinidad, Turkey, Ukraine United Arab Emirates and Venezuela.
  • 제품 설명
    Liquid Alkaline Phosphatase (R2) Reagent Set for the quantitative determination of alkaline phosphatase in serum, Manufactured by Pointe Scientific, Inc.; Catalog no. H A416-R2. In vitro diagnostic.
  • 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