Events

Device Recall PantheraPuncher 9 . 의 리콜

U.S. Food and Drug Administration에 따르면, 해당 리콜 는 United States 에서 PerkinElmer Health Sciences, 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
    68686
  • 사례 위험등급
    Class 2
  • 사례 연번
    Z-2153-2014
  • 사례 시작날짜
    2014-07-01
  • 사례 출판 날짜
    2014-08-06
  • 사례 상황
    Terminated
  • 사례 국가
    United States
  • 사례 종료 날짜
    2015-10-21
  • 사례 출처
    USFDA
  • 사례 출처 URL
    https://www.accessdata.fda.gov/scripts/cdrh/cfdocs/cfres/res.cfm?id=128446
  • 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
    Panthera-Puncher 9 . - Product Code ooo
  • 원인
    Risk of incorrect results from samples prepared with panthera-puncher 9.
  • 조치
    Perkin Elmer sent an Urgent Medical Device Recall letter dated July 1, 2014, to all affected customers. The letter identified the product the problem and the action needed to be taken by the customer. The Recall Letter delivered to the end customer by email facilitated through our Perkin Elmer Technical Support group located in Akron Ohio. Technical Support will be asked to make sure the customers receive the Recall Letter and implement the recommended precautions: "Removing the plates from the Panthera-Puncher 9 when not actively punching and processing samples in the instrument. "Opening the plate track hatch if plates must reside in the Panthera-Puncher 9 while the instrument is idle or in sleep mode. This will interrupt power to the ionizer and eliminate any ionizer impact on the plate wells. For further information, please contact your local Perkin Eimer representative or GSTechnicaiSupport@PerkinEimer.com. For further information please call (781) 663-6900.

Device

Device Recall PantheraPuncher 9 .
  • 모델명 / 제조번호(시리얼번호)
    Serial Numbers: 20810001 through 20810148
  • 유통
    Worldwide Distribution - USA (nationwide) and the countries of : Canada, Australia, Brazil, China, Denmark, Great Britain, Italy, France, Mexico, Qatar and Korea.
  • 제품 설명
    Panthera-Puncher 9 . || Panthera-Puncher 9 is a sample transfer instrument for professional use. The sample, a dried blood disk, is extracted from a larger area of the sample (dried blood spot) by punching the disk of the specified size to a sample collection vessel, e.g. a 96-well microtiter plate. The identification of the sample punched to a specific well of the plate is stored and carried on to the next instrument or the data is transferred to the LIMS.
  • Manufacturer
    PerkinElmer Health Sciences, Inc.

Manufacturer

PerkinElmer Health Sciences, Inc.
  • 제조사 주소
    PerkinElmer Health Sciences, Inc., 940 Winter St, Waltham MA 02451-1457
  • 제조사 모회사 (2017)
    Perkin Elmer Inc.
  • Source
    USFDA