Events

Pacific Hemostasis ThromboplastinDS 의 리콜

U.S. Food and Drug Administration에 따르면, 해당 리콜 는 United States 에서 Fisher Diagnostics, A Company of Fisher Scientific LLC 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
    57107
  • 사례 위험등급
    Class 2
  • 사례 연번
    Z-1519-2011
  • 사례 시작날짜
    2010-10-06
  • 사례 상황
    Terminated
  • 사례 국가
    United States
  • 사례 종료 날짜
    2011-11-02
  • 사례 출처
    USFDA
  • 사례 출처 URL
    https://www.accessdata.fda.gov/scripts/cdrh/cfdocs/cfres/res.cfm?id=95403
  • 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
    Test, time, prothrombin - Product Code GJS
  • 원인
    An in vitro diagnostic reagent used in coagulation testing may cause inaccurate clotting times in quality control and patient plasma samples.
  • 조치
    The firm, ThermoFisher Scientific, sent two "Urgent Medical Device Removal" letters one via Federal Express on October 20, 2010 and certified mail for domestic customers on October 21, 2010. The letters described the product, problem and action to be taken by the customers. The customers were instructed to indicate the quantities of all affected product currently in stock at their facility; complete and return the attached Response Form/table to Fisher Diagnostics via fax to (540) 869-8129 or by mail to the attention of Technical Support; dispose of any remaining inventory of the affected lot numbers; provide a copy of this letter to their customers, and file this letter for future reference. If you have any questions regarding this notification, please contact our Technical Support staff at 800-528-0494, Option 2, or email techsupport.diagnostics.mtn@themofisher.com.

Device

Pacific Hemostasis ThromboplastinDS
  • 모델명 / 제조번호(시리얼번호)
    V40526, exp 4/2013 V40826, exp 4/2013
  • 의료기기 분류등급
    Hematology and Pathology Devices
  • 의료기기 등급
    2
  • 이식된 장치?
    No
  • 유통
    Worldwide distribution: USA including states of: Alaska, Florida, Kentucky, Ohio, New Jersey, New York, and Texas; and countries including: Argentina, Dubai, Italy, Mexico, Philippines, Romania, and Turkey.
  • 제품 설명
    Pacific Hemostasis ¿ Thromboplastin-DS, catalog #100354, packaged in 4 mL lypholyzed vials, 10 bottles/carton. Vials are labeled, in part ***Fisher Diagnostics a division of Fisher Scientific Company, LLC Middletown, VA 22645-1905 USA*** || Thromboplastin-DS is a Class 2 medical device intended for use in performing the one stage prothrombin time (PT) test and PT-based factor assays.
  • Manufacturer
    Fisher Diagnostics, A Company of Fisher Scientific LLC

Manufacturer

Fisher Diagnostics, A Company of Fisher Scientific LLC
  • 제조사 주소
    Fisher Diagnostics, A Company of Fisher Scientific LLC, 8365 Valley Pike, Middletown VA 22645-1905
  • 제조사 모회사 (2017)
    Thermo Fisher Scientific Inc
  • Source
    USFDA