Events

Pro Time Microcoagulation System/ Pro Time 3 Cuvette 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
    64076
  • 사례 위험등급
    Class 2
  • 사례 연번
    Z-0837-2013
  • 사례 출판 날짜
    2013-02-19
  • 사례 상황
    Terminated
  • 사례 국가
    United States
  • 사례 종료 날짜
    2014-01-09
  • 사례 출처
    USFDA
  • 사례 출처 URL
    https://www.accessdata.fda.gov/scripts/cdrh/cfdocs/cfres/res.cfm?id=115328
  • 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
    Some pro time3 test cuvettes within a specified lot range may recover lower than expected prothrombin time/international normalized ratio (pt/inr) results.
  • 조치
    ITC sent an 'Urgent Medical Device Recall' letter/Health Professional Account Tracking Form dated October 2, 2012, to all affected customers. The letter identified the product, the problem, and the action to be taken by the customer. Customers were asked to complete the form whether or not they have remaining inventory of these lots and return the form promptly. All unused returned product will be replaced. Any questions can be directed to ITC Technical Support at 800-631-5945 Extension 4707 or e-mail ProTime@itcmed.com. For questions regarding this recall call 800-631-5945, ext. 4707.

Device

Pro Time Microcoagulation System/ Pro Time 3 Cuvette
  • 모델명 / 제조번호(시리얼번호)
    Pro3-25    A2K3C001 1/31/2013 A2K3C002 1/31/2013 A2P3C003 1/31/2013 A2P3C004 1/31/2013 A2K3C005 1/31/2013 A2K3C006 1/31/2013 A2K3C007 1/31/2013 A2K3C008 1/31/2013 A2K3C009 1/31/2013 A2K3C011 1/31/2013 A2K3C013 1/31/2013 A2K3C015 1/31/2013 A2K3C016 1/31/2013 A2K3C017 1/31/2013 A2K3C018 1/31/2013 A2K3C019 1/31/2013 A2K3C020 1/31/2013 A2K3C021 1/31/2013 A2K3C022 1/31/2013 A2K3C023 1/31/2013 A2K3C0241/31/2013 A2K3C025 1/31/2013 A2K3C026 1/31/2013 A2K3C027 1/31/2013 B2K3C028 2/28/2013  B2K3C030 2/28/2013 B2K3C031 2/28/2013 B2K3C032 2/28/2013 B2K3C033 2/28/2013 B2K3C034 2/28/2013 B2K3C035 2/28/2013 B2K3C036 2/28/2013 B2K3C037 2/28/2013 B2K3C038 2/28/2013 B2K3C039 2/28/2013 B2K3C040 2/28/2013 B2K3C041 2/28/2013 B2K3C042 2/28/2013 B2K3C043 2/28/2013 B2K3C044 2/28/2013 B2K3C045 2/28/2013 B2K3C046 2/28/2013 C2K3C048 3/31/2013 C2K3C049 3/31/2013 C2K3C050 3/31/2013 C2K3C051 3/31/2013 C2K3C052 3/31/2013 C2K3C053 3/31/2013 C2K3C054 3/31/2013 C2K3C055 3/31/2013 C2K3C056 3/31/2013 C2K3C058 3/31/2013 C2K3C059 3/31/2013 C2K3C061 3/31/2013 D2K3C078 4/30/2013 M1K3C474 12/31/2012 M1K3C475 12/31/2012 M1K3C476 12/31/2012 M1K3C477 12/31/2012 M1P3C478 12/31/2012 M1P3C479 12/31/2012 M1P3C480 12/31/2012 M1P3C481 12/31/2012 M1P3C482 12/31/2012   PRO3-4  A2K3H015 1/31/2013 B2K3H029 2/28/2013 B2K3H033 2/28/2013 B2K3H047 2/28/2013 C2K3H049 3/31/2013 C2K3H055 3/31/2013 C2K3H057 3/31/2013  PRO3-50  B2P3C029 2/28/2013 B2P3C030 2/28/2013 B2P3C033 2/28/2013 C2P3C057 3/31/2013
  • 의료기기 분류등급
    Hematology and Pathology Devices
  • 의료기기 등급
    2
  • 이식된 장치?
    No
  • 유통
    Worldwide Distribution - USA (nationwide) and Internationally to Bermuda, Canada, Chile, Denmark, Germany, Italy, Latvia, Lithuania, Malaysia, Philippines, South Africa, Spain, Switzerland, Taiwan, and United Arab Emirates.
  • 제품 설명
    Pro Time Microcoagulation System/ Pro Time 3 Cuvette, Pro3-4, Pro3-25, and Pro3-50. || International Technidyne Corporation. || The Pro Time Microcoagulation System is a portable battery operated instrument with a disposable cuvette for quantitative determination of prothrombin time from fingerstick whole blood or anticoagulant free venous whole blood.
  • Manufacturer
    International Technidyne Corp.

Manufacturer

International Technidyne Corp.
  • 제조사 주소
    International Technidyne Corp., 68 Olsen Ave, Edison NJ 08820-2419
  • 제조사 모회사 (2017)
    Werfenlife Sa.
  • Source
    USFDA