Events

Device Recall Pointe Scientific Liquid Hitachi Calcium 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
    53784
  • 사례 위험등급
    Class 2
  • 사례 연번
    Z-1041-2010
  • 사례 시작날짜
    2009-11-10
  • 사례 출판 날짜
    2010-03-10
  • 사례 상황
    Terminated
  • 사례 국가
    United States
  • 사례 종료 날짜
    2010-12-10
  • 사례 출처
    USFDA
  • 사례 출처 URL
    https://www.accessdata.fda.gov/scripts/cdrh/cfdocs/cfres/res.cfm?id=86517
  • 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
    Calcium Reagent Set - Product Code CIC
  • 원인
    Non-compliance with the good manufacturing practice regulations, as the manufacturing process for this product had not been validated.
  • 조치
    Consignees were notified by "Urgent: Medical Device Recall" letter dated November 11, 2009 and instructed to conduct a recall to the retail level, that users should dispose of the product immediately, and that a business reply card should be returned to account for products. If you have any questions, please call Pointe Scientific, Inc. Technical Support Department at 1-800-757-5313 or 1-734-487-8300.

Device

Device Recall Pointe Scientific Liquid Hitachi Calcium Reagent Set
  • 모델명 / 제조번호(시리얼번호)
    All lots containing 813401 as part of the lot number.
  • 의료기기 분류등급
    Clinical Chemistry and Clinical Toxicology Devices
  • 의료기기 등급
    2
  • 이식된 장치?
    No
  • 유통
    Worldwide Distribution (United States, Chile, India, Republic of Yemen and Trinidad).
  • 제품 설명
    Calcium (CPC) R2 Reagent Set. Pointe Scientific Liquid Calcium (CPC) R2 Reagent Set, Pointe Scientific, Inc, Canton, MI; Catalog #'s HC402-R2. Calcium CPC Hitachi Reagent Set for repackaging, Catalog # 3-HC902-R2. || The product is used for the quantitative determination of calcium in serum on Hitachi analyzers.
  • Manufacturer
    Pointe Scientific, Inc.

Manufacturer

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