Events

Inverness Medical BioStar Strep A OIA MAX 의 리콜

U.S. Food and Drug Administration에 따르면, 해당 리콜 는 United States 에서 Binax, Inc. dba IMPD 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
    51871
  • 사례 위험등급
    Class 2
  • 사례 연번
    Z-1506-2009
  • 사례 시작날짜
    2009-04-06
  • 사례 출판 날짜
    2009-06-24
  • 사례 상황
    Terminated
  • 사례 국가
    United States
  • 사례 종료 날짜
    2010-01-06
  • 사례 출처
    USFDA
  • 사례 출처 URL
    https://www.accessdata.fda.gov/scripts/cdrh/cfdocs/cfres/res.cfm?id=81490
  • 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
    strep test in vitro diagnostic - Product Code GTZ
  • 원인
    Potential for false positive strep a results.
  • 조치
    Inverness Medical notified Customers by letter sent via Fedex April 6, 2009 . The letter included a request for a response from the customer. The product is discontinued.

Device

Inverness Medical BioStar Strep A OIA MAX
  • 모델명 / 제조번호(시리얼번호)
    All lots: 196070, 196071, 196073, 196074, and 198052 expire 05/31/09;  196278, 196279, 196280, and 196281, expire 06/30/09.
  • 의료기기 분류등급
    Immunology and Microbiology Devices
  • 의료기기 등급
    1
  • 이식된 장치?
    No
  • 유통
    Nationwide.
  • 제품 설명
    Inverness Medical BioStar Strep A OIA MAX, 100 test kit size, || Product Code: 90003, in vitro diagnostic.
  • Manufacturer
    Binax, Inc. dba IMPD

Manufacturer

Binax, Inc. dba IMPD
  • 제조사 주소
    Binax, Inc. dba IMPD, 10 Southgate Rd, Scarborough ME 04074
  • 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