Events

Leica Microsystems, Inc. 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
    72288
  • 사례 위험등급
    Class 2
  • 사례 연번
    Z-0341-2016
  • 사례 시작날짜
    2015-09-03
  • 사례 출판 날짜
    2015-11-25
  • 사례 상황
    Terminated
  • 사례 국가
    United States
  • 사례 종료 날짜
    2017-11-30
  • 사례 출처
    USFDA
  • 사례 출처 URL
    https://www.accessdata.fda.gov/scripts/cdrh/cfdocs/cfres/res.cfm?id=140480
  • 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
    These lot numbers are not stable up to the expiry date on the product labeling.
  • 조치
    Leica sent a MEDICAL DEVICE RECALL NOTIFICATION letter dated September 3, 2015 via mail to all of the consignees. The letter identified the affected, product, problem and actions to be taken. Customers are instructed to discontinue use of the reagent lots listed in the recall notification. It is requested that customers appropriately destroy any unused or partially used affected lots of the reagent, and indicate on the attached Medical Device Recall Notification Acknowledgement Form that this action has been undertaken. Customers were asked to confirm receipt of the notice as soon as possible by signing and dating the attached Medical Device Recall Notification Acknowledgement Form and fax it back to1-847-236-3747, to receive your alternative replacement for applicable orders. For questions contact your local Leica representative.

Device

Leica Microsystems, Inc.
  • 모델명 / 제조번호(시리얼번호)
    CD10-270-CE-S (0.1 ml) 6033086 (U.S. Distribution) expire 06/2016, 6032390 expires 04/2016, 6033622 expires 07/2016.   CD10-270-CE (1ml) 6032742 (U.S. Distribution) expires 11/2017.
  • 의료기기 분류등급
    Hematology and Pathology Devices
  • 의료기기 등급
    1
  • 이식된 장치?
    No
  • 유통
    Worldwide Distribution - US Nationwide, Australia, Austria, Brazil, Canada, China, Czech Republic, Finland, France, Germany, Hungary, Indonesia, Ireland, Israel, Italy, Japan, Netherlands, Norway, Romania, Singapore, Slovenia, South Korea, Spain, Sweden, Switzerland and UK.
  • 제품 설명
    Novocastra Lyophilized Mouse Monoclonal Antibody CD10 (CD10). Immunohistochemistry. in vitro diagnostic. 0.1ml NCL-CD10-270 and 1mL NCL-CD10-270 are intended for the qualitative identification by light microscopy of CD10 molecules in paraffin sections.
  • 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