Device Recall Pipette tips: Item Number: 6000689 25 L Clear Filter Sterile Roborack, Qty 960 의 리콜

U.S. Food and Drug Administration에 따르면, 해당 리콜 는 United States 에서 PerkinElmer, 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
    75508
  • 사례 위험등급
    Class 2
  • 사례 연번
    Z-0747-2017
  • 사례 시작날짜
    2016-06-24
  • 사례 상황
    Terminated
  • 사례 국가
  • 사례 종료 날짜
    2018-07-31
  • 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
    Filter tips molded incorrectly and may not seal to the varispan tip adaptor properly causing inaccurate aspiration and dispensing.
  • 조치
    PerkinElmer initiated recall on June 24, 2016 to the Product Manager and was delivered to the customer by email facilitated through PerkinElmer Sales Team.Customers were requested to take the following actions until PerkinElmer's corrective measures are completed: Inspect customer inventory of the 6000689 25 Clear Filter Pipette Tip and identify if the affected lots are present. Complete and return the attached Response Form with the required information. Destroy all quantities of tips from the affected lots. Upon receipt of the return Response Form, a shipment of replacement tips will be shipped.

Device

  • 모델명 / 제조번호(시리얼번호)
    Lot Numbers:15470394, 15471775, 1601067, 16071147
  • 의료기기 분류등급
  • 의료기기 등급
    1
  • 이식된 장치?
    No
  • 유통
    Worldwide Distribution - US including CA, MA, NY, IA, OR , PA, WA and Internationally to Belgium, Canada, Finland, France, Germany, Japan, Netherlands, Singapore, and UK
  • 제품 설명
    Perkin Elmer RoboRack 25ul, Clear, Non-Conductive, Filter Tips, Pre-sterilized || Item Number: 6000689. || Supplied for use with JANUS Automated Workstations: || Product Number: AJS4001 AJM4001 AJI4001, AJL4001, AJS8001 , AJM8001, AJI8001, AJL8001, AJM4G01 , AJI4G01 , AJL4G01, AJM8G01, AJI8G01, AJL8G01, AJM4M01, AJI4M01 , AJL4M01, AJM8M01, AJI8M01, AJL8M01, AGS4NGS || The JANUS Automated Workstation is an automated, programmable liquid handling instrument intended for use in clinical settings to facilitate the pipetting and dilution of solutions in sample preparation work flows. The NGS Express is an automated, programmable liquid handling instrument suitable for use in clinical settings to facilitate the pipetting and dilution of solutions in sample preparation workflows
  • Manufacturer

Manufacturer

  • 제조사 주소
    PerkinElmer, Inc, 68 Elm St, Hopkinton MA 01748-1602
  • 제조사 모회사 (2017)
  • Source
    USFDA