Events

INRatio/INRatio2 Test Strips 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
    68038
  • 사례 위험등급
    Class 1
  • 사례 연번
    Z-1546-2014
  • 사례 시작날짜
    2014-04-16
  • 사례 출판 날짜
    2014-05-08
  • 사례 상황
    Terminated
  • 사례 국가
    United States
  • 사례 종료 날짜
    2017-07-19
  • 사례 출처
    USFDA
  • 사례 출처 URL
    https://www.accessdata.fda.gov/scripts/cdrh/cfdocs/cfres/res.cfm?id=126845
  • 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
    Test strips may report an inaccurately low inr result. several patients had a therapeutic or near-therapeutic inr with the alere inratio2 pt/inr professional test strip but a significantly higher inr (outside of therapeutic range) when performed by a central laboratory.
  • 조치
    Alere sent an Urgent: Medical Device Recall letter dated April 16, 2014 via fax, email or direct mail. The letter identified the affected product, problem and actions to be taken. Customers were instructed to discontinue use, return remaining inventory to Alere, and complete the provided verification form to acknowledge receipt of the recall notice. For questions contact Alere Technical Service by phone at 844-292-5373 or by E-mail at INRatio.Notification@alere.com. UPDATED: On 05/06/2014, Alere issued a press release on this recall to the consumer/public level. The press release, dated May 6, 2014, announced Alere Inc.s voluntary Class I recall in the U.S. of the Alere INRatio2 PT/INR Professional Test Strips (PN 99008G2). The press release also stated the following information: reason for recall, any adverse event reports, reason for the adverse event reports , root cause not yet determined, notified customers to immediately STOP using the product, product description with codes, contact information, FDA MedWatch information and about Alere and About the Alere INRation2 PT/INR Professional Monitoring System.

Device

INRatio/INRatio2 Test Strips
  • 모델명 / 제조번호(시리얼번호)
    Lot/Unit Codes: Applicable to all Alere INRatio2 PT/INR Professional Test Strips lots packaged from 8/22/13 through 3/28/14, including the following: 324810, 324811, 324812, 327543, 327544, 327549, 328109, 328705, 328707, 330238, 330852, 331340, 331916, 331922, 332841, 332842, 332843, 332959, 333362, 333654, 333655, 333864, 333865, 334572, 334575, 335552, 335553, 335796, 335797, 336426, 336668, 337350, 338965, 338966, 339257, 339707, 327856V Expiration date, or Expected shelf life: range from 4/30/14 to 1/31/15
  • 의료기기 분류등급
    Hematology and Pathology Devices
  • 의료기기 등급
    2
  • 이식된 장치?
    No
  • 유통
    US Nationwide Distribution
  • 제품 설명
    Alere INRatio2 PT/INR Professional Test Strips, Model Number: 99008G2. The Alere INRatio2 PT/INR Monitoring System (Professional Use), consisting of the Monitor and test strip, is used for quantitative determination of international normalized ratio (INR) in fresh, capillary whole blood to monitor the effect of warfarin therapy on clotting time by health care professionals. (in vitro diagnostic use).
  • 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