Events

HemosIL ReadiPlasTin 의 리콜

U.S. Food and Drug Administration에 따르면, 해당 리콜 는 United States 에서 Instrumentation Laboratory Co. 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
    79165
  • 사례 위험등급
    Class 2
  • 사례 연번
    Z-0895-2018
  • 사례 시작날짜
    2017-08-02
  • 사례 상황
    Open, Classified
  • 사례 국가
    United States
  • 사례 출처
    USFDA
  • 사례 출처 URL
    https://www.accessdata.fda.gov/scripts/cdrh/cfdocs/cfres/res.cfm?id=161501
  • 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
    Instrumentation laboratory co. received customer reports of performance issues with some vials of lot nos. n1166235 and n0177760, including increased imprecision, out of range quality controls and prolonged sample results.
  • 조치
    Instrumentation Laboratory sent an Urgent Medical Device Removal letter dated August 2, 2017 to their customers. The letter identified the affected product, problem and actions to be taken. . Customers were instructed to complete a Mandatory Tracking Response form. For questions contact your Customer Service Representative at 1-800-955-9525, option #1.

Device

HemosIL ReadiPlasTin
  • 모델명 / 제조번호(시리얼번호)
    Lots: N1166235 and N0177760.
  • 의료기기 분류등급
    Hematology and Pathology Devices
  • 의료기기 등급
    2
  • 이식된 장치?
    No
  • 유통
    Worldwide Distribution - US Nationwide
  • 제품 설명
    Hemosll ReadiPlasTin (20 ml Size), Part Number 0020301400 || Product Usage: || HemosIL¿ ReadiPlasTin is an in vitro diagnostic thromboplastin reagent, based on recombinant human tissue factor, for the quantitative determination, in human citrated plasma, of Prothrombin Time (PT) and Fibrinogen, on the ACL TOP¿ Family of analyzers. The product is intended to be used for the evaluation of the extrinsic coagulation pathway and the monitoring of Oral Vitamin K Antagonist Therapy.
  • Manufacturer
    Instrumentation Laboratory Co.

Manufacturer

Instrumentation Laboratory Co.
  • 제조사 주소
    Instrumentation Laboratory Co., 180 Hartwell Rd, Bedford MA 01730-2443
  • 제조사 모회사 (2017)
    Werfenlife Sa.
  • Source
    USFDA