Events

Device Recall HEMOCHRON(R) HEPARIN RESPONSE TEST 의 리콜

U.S. Food and Drug Administration에 따르면, 해당 리콜 는 United States 에서 International Technidyne Corp. 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
    56114
  • 사례 위험등급
    Class 2
  • 사례 연번
    Z-2110-2010
  • 사례 시작날짜
    2010-06-24
  • 사례 출판 날짜
    2010-07-28
  • 사례 상황
    Terminated
  • 사례 국가
    United States
  • 사례 종료 날짜
    2010-09-23
  • 사례 출처
    USFDA
  • 사례 출처 URL
    https://www.accessdata.fda.gov/scripts/cdrh/cfdocs/cfres/res.cfm?id=92693
  • 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
    assay, heparin - Product Code KFF
  • 원인
    An ingredient in the rqchrt whole blood controls for use with hemochron kaolin and celite hrt test tubes may become less potent over time and result in excessive high lqc failures.
  • 조치
    ITC sent "URGENT MEDICAL DEVICE RECALL" letters dated June 24, 2010, via Federal Express to Laboratory Director, Clinical Laboratory Manager, or Point of Care Coordinator consignees/customers. The letter described the product, problem and action to be taken by customers. The customers were instructed to check their inventory for the product, if they have boxes or loose vials to please stop using the product, remove it from inventory and contact ITC Technical Support to arrange return. They were also instructed to complete the attached Customer Account Tracking Form, whether or not they have remaining inventory, and return it by fax, email or mail. If you have any questions, please call ITC Technical Support at 800-631-5945 (US) or 732-548-5700 (international), Extension 4707 or email techsupport@itcmed.com.

Device

Device Recall HEMOCHRON(R) HEPARIN RESPONSE TEST
  • 모델명 / 제조번호(시리얼번호)
    Test kit lot numbers: H9KHR002, Exp 05/2010 and BOKHR001, Exp 08/2010; RAF 10-016
  • 의료기기 분류등급
    Hematology and Pathology Devices
  • 의료기기 등급
    2
  • 이식된 장치?
    No
  • 유통
    Worldwide distribution: USA including states of CA, NC, TX, FL, MD, OK, NY, and NJ and country of Italy.
  • 제품 설명
    RQCHRT HRT Control Level 1 & 2; || Whole Blood controls for use with Hemochron Kaolin and Celite HRT Test Tubes. || 20 vials Whole Blood - 2.0mL; dried || 20 vials Diluent - 4.0 mL || The Hemochron HRT Whole Blood Quality Controls are intended to be used to perform quality control assays using the Hemochron HRT test tubes.
  • Manufacturer
    International Technidyne Corp.

Manufacturer

International Technidyne Corp.
  • 제조사 주소
    International Technidyne Corp., 6-8 Olsen Avenue, Edison NJ 08820-2419
  • 제조사 모회사 (2017)
    Werfenlife Sa.
  • Source
    USFDA