Events

Device Recall Leica Biosystems Newcastle 의 리콜

U.S. Food and Drug Administration에 따르면, 해당 리콜 는 United States 에서 Leica Microsystems, 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
    73095
  • 사례 위험등급
    Class 2
  • 사례 연번
    Z-0823-2016
  • 사례 시작날짜
    2015-12-30
  • 사례 출판 날짜
    2016-02-19
  • 사례 상황
    Terminated
  • 사례 국가
    United States
  • 사례 종료 날짜
    2017-01-05
  • 사례 출처
    USFDA
  • 사례 출처 URL
    https://www.accessdata.fda.gov/scripts/cdrh/cfdocs/cfres/res.cfm?id=143048
  • 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
    Immunohistochemistry reagents and kits - Product Code NJT
  • 원인
    The bond" polymer refine detection and novolink" polymer detection system may not provide adequate staining when using a detection protocol where one of its components - peroxide block / peroxidase block is applied after the primary marker incubation as specified in the instructions for use following the instructions for use.
  • 조치
    The firm sent out a Medical Device Recall letter dated December 29th 2015 to two-hundred (200) consignees in the United States decribing the recall and the neccesary actions to be taken. These included: - Do not use or continue to use the listed antibody with the specified detection kits. - Order replacement detection kits for use with the listed antibody. - There is no need for retrospective review of tissue staining if appropriate positive controls were properly used and interpreted during the immuno / in-situ staining. -pass this notice primarily to the end users where the product has been sold and to all those within your organization who need to be aware of this issue. -Confirm reciept of the Recall Notice letter by signing and dating the attached Acknowledgement Form and faxing it back to us at 1-847-236-3747, or scan and email it to LMGRA@Leica-Microsystems.com Customer are requested to contact their local Leica representative if you have any questions or concerns, or alternatively please contact us at the following email address: Combination.Products@LeicaBiosystems.com Peter Lloyd Leica Biosystems Newcastle Ltd Balliol Business Park West Benton Lane Newcastle upon Tyne NE 12 8EW United Kingdom Telephone +44 191 215 0567 Facsimile: +44 191 215 1152

Device

Device Recall Leica Biosystems Newcastle
  • 모델명 / 제조번호(시리얼번호)
    Product Code/Name: PA0552 (All Lots) Bond Ready-to-Use Primary Antibody PAX-5 (1EW).   Detection Kit: DS9800 BondTM Polymer Refine Detection Kit. Affected Detection Kit Lots: 42314, 42388, 42474, 42486, 42499, 42555, 42570, 42579, 42627, 42645, 42683, 42780, 42802, 42823, 42852, 43050.
  • 의료기기 분류등급
    Hematology and Pathology Devices
  • 의료기기 등급
    1
  • 이식된 장치?
    No
  • 유통
    US Consignees incluude: AR ,AZ ,CA ,CO ,CT ,DC ,DE ,FL ,GA ,HI ,IA ,IL ,KY ,LA ,MA ,MD ,MI ,MN ,MO ,MT ,NC ,NH ,NJ ,NY ,OH ,OK ,PA ,PR ,SC ,TN ,TX ,UT ,VA ,VT ,WA ,WI and WV. Foreign Consignees include:Argentina , Australia , Brazil , Bulgaria , Chile , China , Ecuador ,Egypt , El Salvador , Finland , France , Georgia , Germany , Greece , India , Italy , Japan , Jordan , Kuwait , Lebanon , Malaysia , Philippines , Poland , Portugal , Romania , Russian Fed. , Singapore , South Korea , Spain , Sweden , Switzerland , Thailand , Tunisia , Turkey , United Kingdom and United Arab Emirates.
  • 제품 설명
    This reagent is for in vitro diagnostic use. Pax-5 (1EW) monoclonal antibody is intended to be used for the qualitative identification by light microscopy of human Pax-5 in formalin-fixed, paraffin-embedded tissue by immunohistochemical staining using the automated Bond system.
  • Manufacturer
    Leica Microsystems, Inc.

Manufacturer

Leica Microsystems, Inc.
  • 제조사 주소
    Leica Microsystems, Inc., 1700 Leider Ln, Buffalo Grove IL 60089-6622
  • 제조사 모회사 (2017)
    Danaher Corporation
  • Source
    USFDA