Events

ARCHITECT cSystem 의 리콜

U.S. Food and Drug Administration에 따르면, 해당 리콜 는 United States 에서 Abbott Laboratories, 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
    44961
  • 사례 위험등급
    Class 2
  • 사례 연번
    Z-0146-2008
  • 사례 시작날짜
    2007-09-05
  • 사례 출판 날짜
    2007-11-07
  • 사례 상황
    Terminated
  • 사례 국가
    United States
  • 사례 종료 날짜
    2010-10-04
  • 사례 출처
    USFDA
  • 사례 출처 URL
    https://www.accessdata.fda.gov/scripts/cdrh/cfdocs/cfres/res.cfm?id=64656
  • 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
    Processing Module, for In Vitro Diagnostics; - Product Code JJE
  • 원인
    Incorrect sample/test identification: due to a software timing defect with certain versions of architect csystem software, test results may be incorrectly associated to a sample identification during specific sample-processing conditions of the robotic sample handler.
  • 조치
    Notification letters sent to consignees on 09/17/07. Consignees informed of the software defect and the conditions that would cause the software error to occur. Consignees told they would be contacted by an Abbott Field Service Rep who would install ARCHITECT System Software v3.11 and were asked to respond via fax using Customer Reply form acknowledging receipt and understanding of correction letter. Firm recalling to hospital/user level.

Device

ARCHITECT cSystem
  • 모델명 / 제조번호(시리얼번호)
    All Serial Numbers: ARCHITECT cSystems using ARCHITECT System Software Versions: ---Software Version--List Number--Part Number-- 2.10-- 05F48-11-- 7-99077-01 2.11-- 05F48-12 --7-99077-02 2.12 --None --------7-99077-03 2.20 --05F48-13 ---7-201738-01 2.20DB --05F48-14 ---7-201738-02 2.30-- None --202246-01 2.60-- 05F48-17-- 7-203715-01 3.00-- 05F48-15-- 7-202246-01 3.10-- 05F48-18-- 7-203715-02
  • 의료기기 분류등급
    Clinical Chemistry and Clinical Toxicology Devices
  • 의료기기 등급
    1
  • 이식된 장치?
    No
  • 유통
    Worldwide Distribution: USA (including Puerto Rico), Argentina, Australia, Bahamas, Bermuda, Brazil, Cayman Islands, Canada, Chile, China, Colombia, Dominican Republic, Ecuador, El Salvador, Germany, Guatemala, Hong Kong, Jamaica, Mexico, New Zealand, Panama, Singapore, Thailand, Trinidad and Tobago, Uruguay, and Venezuela.
  • 제품 설명
    ARCHITECT c8000 Processing Module, for In Vitro Diagnostics; List Number 106-01; Affected software: v2.10, v2.11, v2.12, v2.20, v2.20DB, v2.30, v2.60, v3.00 and v3.10; Distributed by Abbott Laboratories, Irving, TX.
  • Manufacturer
    Abbott Laboratories, Inc

Manufacturer

Abbott Laboratories, Inc
  • 제조사 주소
    Abbott Laboratories, Inc, 1921 Hurd Drive, PO Box 152020, Irving TX 75038
  • Source
    USFDA