Events

RAPID SYPHILIS TEST KIT, per insert, contents of the kit are: 1 Rapid Syphilis test cassette, 1 alcohol swab, 1 buffer container, 1 lancet (needle), 1 zipped bag, 1 pipette (plastic) (included with cassette). There is no firm identified on the product packaging. 의 리콜

U.S. Food and Drug Administration에 따르면, 해당 리콜 는 United States 에서 Ups Supply Chain Solutions 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
    31097
  • 사례 위험등급
    Class 2
  • 사례 연번
    Z-0542-05
  • 사례 시작날짜
    2005-02-04
  • 사례 출판 날짜
    2005-02-15
  • 사례 상황
    Terminated
  • 사례 국가
    United States
  • 사례 종료 날짜
    2005-07-27
  • 사례 출처
    USFDA
  • 사례 출처 URL
    https://www.accessdata.fda.gov/scripts/cdrh/cfdocs/cfres/res.cfm?id=37141
  • 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
  • 원인
    The kits are not approved for use in the united states.
  • 조치
    Letters dated February 4, 2005, flagged 'Important Safety Notice -- Test Kit Recall' with instructions to consumers to destroy kits and to consult a health care professional if they have used the test kit. Letters will require a signed receipt. Letterhead used identifies recalling firm as 'FDTS'.

Device

RAPID SYPHILIS TEST KIT, per insert, contents of the kit are: 1 Rapid Syphilis test cassette, 1 ...
  • 모델명 / 제조번호(시리얼번호)
    All lots are subject to recall.
  • 유통
    Consumers throughout the United States.
  • 제품 설명
    RAPID SYPHILIS TEST KIT, per insert, contents of the kit are: 1 Rapid Syphilis test cassette, 1 alcohol swab, 1 buffer container, 1 lancet (needle), 1 zipped bag, 1 pipette (plastic) (included with cassette). There is no firm identified on the product packaging.
  • Manufacturer
    Ups Supply Chain Solutions

Manufacturer

Ups Supply Chain Solutions
  • 제조사 주소
    Ups Supply Chain Solutions, 12380 Morris Rd, Alpharetta GA 30005-4177
  • Source
    USFDA