Device Recall VITEK GPS107 Gram Positive Susceptibility Card 의 리콜

U.S. Food and Drug Administration에 따르면, 해당 리콜 는 United States 에서 bioMerieux 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
    28431
  • 사례 위험등급
    Class 1
  • 사례 연번
    Z-0721-04
  • 사례 시작날짜
    2004-01-28
  • 사례 출판 날짜
    2004-07-20
  • 사례 상황
    Terminated
  • 사례 국가
  • 사례 종료 날짜
    2005-04-18
  • 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
    System, Test, Automated, Antimicrobial Susceptibility, Short Incubation - Product Code LON
  • 원인
    Some of the cards were stamped with an incorrect card code causing the system to read and report the cards incorrectly.
  • 조치
    The firm issued recall letters dated 1/28/04 via regular mail requesting remaining inventories be destroyed and explaining the method which the customer can use to confirm the cards were not misreported. A 'Second Notification' recall letter was issued dated 3/9/04.

Device

  • 모델명 / 제조번호(시리얼번호)
    Lot #M83X, Exp. 4/15/05
  • 의료기기 분류등급
  • 의료기기 등급
    2
  • 이식된 장치?
    No
  • 유통
    Distribution was made nationwide to medical facilities, which includes military and government consignees. Distribution was also made to foreign consignees located in Colombia, Costa Rica, and China.
  • 제품 설명
    VITEK GPS-107Gram Positive Susceptibility Card, Catalog #V4368, for in-vitro diagnostic use, 20 cards per package. The responsible firm on the label is bioMerieux, Inc., Durham, NC.
  • Manufacturer

Manufacturer

  • 제조사 주소
    bioMerieux Inc, 595 Anglum Rd, Hazelwood MO 63042-2320
  • Source
    USFDA