Events

Device Recall INRatio Monitors 의 리콜

U.S. Food and Drug Administration에 따르면, 해당 리콜 는 United States 에서 Alere San Diego, 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
    69964
  • 사례 위험등급
    Class 1
  • 사례 연번
    Z-0881-2015
  • 사례 시작날짜
    2014-12-05
  • 사례 출판 날짜
    2015-01-03
  • 사례 상황
    Terminated
  • 사례 국가
    United States
  • 사례 종료 날짜
    2017-09-18
  • 사례 출처
    USFDA
  • 사례 출처 URL
    https://www.accessdata.fda.gov/scripts/cdrh/cfdocs/cfres/res.cfm?id=132045
  • 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
    In certain cases, an inratio pt/inr monitor system may provide an inr result that is significantly lower than a result obtained using a reference inr system (laboratory method). this issue can arise if the patient has certain medical conditions. it can also occur if the instructions in the labeling for performing the test are not followed.
  • 조치
    An Urgent: Medical Device Correction, dated December 5, 2014, was sent to Healthcare Professionals. The letter identified the affected product and reason for recall. Customers were instructed to: -Ensure they have read and understand the precautions described in the current product labeling (a complete list of product labeling is provided in Appendix A) and the additional precautions in this notice describing medical conditions that may increase the risk of obtaining a (falsely or erroneously) lower than expected INR result. The INRatio PT/INR Monitor system should NOT be used if the patient has any of the medical conditions described. -Verify that the patient has hematocrit within the range of 30% to 55%. If not, immediately transition the patient to an alternate INR monitoring method. -Perform INR verification testing for the patients using a laboratory INR test method. Immediately transition any patient with a significantly discrepant low result on the INRatio¿¿ PT/INR Monitor system to an alternative INR monitoring method. -If have forwarded product to another customer, please provide a copy of this letter to them. -Please complete and FAX or e-mail the enclosed Reply Form (Appendix B the last page of this notice) within 10 days to confirm your receipt of this notice. Customers can contact Alere INRatio Recall Hotline by phone at 1-877-929-2579, for questions regarding this notification. Additionally, a website has been established providing information and frequently asked questions. www.inr-care.com Please FAX or e-mail the completed Reply Form to: Alere San Diego, Inc. Fax: 1-877-929-2580 E-mail: Alere4319@stericycle.com.

Device

Device Recall INRatio Monitors
  • 모델명 / 제조번호(시리얼번호)
    All lots of part numbers: 0100004, 0100007, and 0100137.
  • 의료기기 분류등급
    Hematology and Pathology Devices
  • 의료기기 등급
    2
  • 이식된 장치?
    No
  • 유통
    Worldwide Distribution -- US nationwide, Canada, South America, EU, Asia Pacific, Africa, and Middle East.
  • 제품 설명
    INRatio Monitors || - 0100004 Alere INRatio PT/INR System Professional || - 0100007 INRatio Prothrombin Time (PT) Monitoring System || - 0100137 Alere INRatio Replacement Monitor || The test systems contain individually packaged components needed to use the product, such as a monitor, user guide, quick reference guide training DVD or CD, Lancets (home monitoring kits contain an Autolet, Unilet, gauze pads, and alcohol wipes), power supply (home monitoring kits contain AA batteries), results log book and a warranty card. None of the components, except for the lancets, are sterile. || In vitro diagnostic monitoring system used for the quantitative measurement of Prothrombin Time (PT) in fresh, capillary whole blood.
  • Manufacturer
    Alere San Diego, Inc.

Manufacturer

Alere San Diego, Inc.
  • 제조사 주소
    Alere San Diego, Inc., 9975 Summers Ridge Rd, San Diego CA 92121-2997
  • 제조사 모회사 (2017)
    Abbott Laboratories
  • 제조사 의견
    “We are in constant communication with regulatory agencies and competent authorities worldwide which allows us to implement global recalls or in-country communication quickly and effectively,” Abbott, which now owns St. Jude Medical told ICIJ in a statement. In addition to sending global notices to physicians worldwide, we also make sure that product advisories are available online and classification of product recalls and product advisories are determined by global regulatory bodies which can impact the timing in any given country. MD companies follow varying regulations in different countries. In come countries software is not regulated so a recall in one country related to software would not be classified as a recall or field action in another. In addition, review cycles within the regulatory process can be different in each country which can impact communication and recall timing.
  • Source
    USFDA