Events

LPC Fine Mesh Cassettes 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
    64968
  • 사례 위험등급
    Class 2
  • 사례 연번
    Z-1446-2013
  • 사례 시작날짜
    2013-04-04
  • 사례 출판 날짜
    2013-06-03
  • 사례 상황
    Terminated
  • 사례 국가
    United States
  • 사례 종료 날짜
    2017-07-21
  • 사례 출처
    USFDA
  • 사례 출처 URL
    https://www.accessdata.fda.gov/scripts/cdrh/cfdocs/cfres/res.cfm?id=117562
  • 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
    Cassettes, tissue - Product Code IDZ
  • 원인
    An lpc fine mesh cassette failed to stay closed during processing operations.
  • 조치
    A Medical Device Correction letter dated April 17, 2013 was sent to customers via USPS 1st class mail. The product issue was described and recommended actions were provided. Customers were requested to acknowledge receipt of the letter by fax-back. Customer questions were directed to (847) 405-5413.

Device

LPC Fine Mesh Cassettes
  • 모델명 / 제조번호(시리얼번호)
    1) Part No.: 14060546848; Batch No.s: 8280-10309, 82801-0310;   2) Part No.: 14060546846; Batch No.s: 1034710114;   3) Part No.: 14060546845; Batch No.s: 1021420914;   4) Part No.: 14060546933; Batch No.s: 82801-0217;   5) Part No.: 14060546932; Batch No.s: 1030730112, 1101110204;   6) Part No.: 14060546852; Batch No.s: 1101910322;   7) Part No.: 14060546850; Batch No.s: 1034710204, 1034710328, 1113910803;   8) Part No.: 14060546847; Batch No.s: 913920827
  • 의료기기 분류등급
    Hematology and Pathology Devices
  • 의료기기 등급
    1
  • 이식된 장치?
    No
  • 유통
    Worldwide distribution: US (nationwide) to states of AZ and KY; and the country of New Zealand.
  • 제품 설명
    LPC Fine Mesh Cassette for the Leica LPC Printer. Part No: 14060546848; 14060546846; 14060546845; 14060546933; 14060546932; 14060546852; 14060546850; 14060546847. The intended use of this device is for storage of specimens/tissues during processing.
  • 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