Device Recall Abbott Molecular Bar Code Scanner User's Guide 의 리콜

U.S. Food and Drug Administration에 따르면, 해당 리콜 는 United States 에서 Abbott Molecular 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
    62329
  • 사례 위험등급
    Class 2
  • 사례 연번
    Z-2013-2012
  • 사례 시작날짜
    2012-01-31
  • 사례 출판 날짜
    2012-07-14
  • 사례 상황
    Terminated
  • 사례 국가
  • 사례 종료 날짜
    2012-12-04
  • 사례 출처
    USFDA
  • 사례 출처 URL
  • 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
    Station, pipetting and diluting, for clinical use - Product Code JQW
  • 원인
    In the abbott molecular bar code scanner user's guide, list number 6l88-02/09, the section modifying the keyboard format for bar code scanner ln 6l89-01 contains incorrect bar codes that can prevent the correct configuration of the bar code scanner language format. the abbott m2000 system is intended for use in performing nucleic acid testing in clinical laboratories. it is comprised of the ab.
  • 조치
    Abbott Molecular Inc. sent an Urgent Field Safety Notice letter dated January 31, 2012, to all affected customers. The letter identified the product the problem and the action needed to be taken by the customer. The customer was instructed to replace the affected pages of the Bar Code Scanner User's Guide with the replacement pages provided with the letter, and immediately perform the Modifying the Keyboard Format section with these replacement pages. The accounts were requested to complete the enclosed reply form and fax it to (847) 775-6728 to acknowledge receipt, understanding and implementation of the information provided in the notice.

Device

  • 모델명 / 제조번호(시리얼번호)
    list numbers 06L88-02, 06L88-03, 06L88-04, 06L88-05, 06L88-06, 06L88-07, 06L88-08 and 06L88-09, all lots
  • 의료기기 분류등급
  • 의료기기 등급
    1
  • 이식된 장치?
    No
  • 유통
    California, Florida, Maryland, Oregon and Virginia, and internationally to Belgium, Brazil, China, France, Germany, Hong Kong, Japan, Malaysia, Mexico, Qatar, Switzerland and United Kingdom
  • 제품 설명
    Abbott Molecular Bar Code Scanner User's Guide; instructions for setting up the Bar Code Scanner LN 6L89-01, a component of the Abbott m2000 Instrument System; Abbott Molecular Inc., Des Plaines, IL 60018 USA; list number 06L88-02. || Language configuration bar codes - Intended Use: The bar code scanner is a hand-held device that provides a convenient means of scanning sample bar codes to allow positive sample identification and is supplementary to the computer keyboard. Both the scanner and the keyboard transmit data to a System Control Center (SCC) through a single wedge (cable with branched connectors). The bar code scanner must be configured to match the keyboard language being used. In its default configuration set by the manufacturer (Jadak), the scanner is in English format. If a keyboard other than the English keyboard is being used, the user is required to use the scanner to scan an appropriate language configuration bar code provided in the User's Guide to match the language of the keyboard. Users in the U.S have the ability to convert to another language.
  • Manufacturer

Manufacturer

  • 제조사 주소
    Abbott Molecular, 1300 E Touhy Ave, Des Plaines IL 60018-3315
  • Source
    USFDA