Events

Device Recall UniCel DxH Slidemaker Stainer Stainer Floor Cabinet 의 리콜

U.S. Food and Drug Administration에 따르면, 해당 리콜 는 United States 에서 Beckman Coulter 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
    62755
  • 사례 위험등급
    Class 2
  • 사례 연번
    Z-2226-2012
  • 사례 시작날짜
    2011-12-13
  • 사례 출판 날짜
    2012-08-20
  • 사례 상황
    Terminated
  • 사례 국가
    United States
  • 사례 종료 날짜
    2012-08-20
  • 사례 출처
    USFDA
  • 사례 출처 URL
    https://www.accessdata.fda.gov/scripts/cdrh/cfdocs/cfres/res.cfm?id=111645
  • 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
    Slide stainer, automated - Product Code KPA
  • 원인
    The recall was initiated because beckman coulter has confirmed that the dxh slidemaker stainer floor stand shipped with slidemaker stainer instruments were missing vinyl caps, exposing sharpt edges on the dxh slidemaker stainer reagent cabinet (floor stand) drawer slides. the sharp edges on the drawer slides may expose operators to physical injury when replacing reagents and waste containers whic.
  • 조치
    Beckman Coulter initiated a "PRODUCT CORRECTIVE ACTION (PCA)" which was communicated via phone calls starting the week of December 19, 2011 to all customers who purchased UniCel DxH Slidemaker Stainer Coulter Cellular Analysis System. The phone calls provided the customers with an explanation of the problem identified, potential impact should the problem occur and an action to be taken. Customers were instructed to share the PCA information with their laboratory staff and if they had any questions, they should contact Beckman Coulter at (800) 526-7694.

Device

Device Recall UniCel DxH Slidemaker Stainer Stainer Floor Cabinet
  • 모델명 / 제조번호(시리얼번호)
    Part Number(s) 775222 and A96152; Serial #s-MP010, MP023, MP026, AS23001, AS23002, AS25003, AS25004, AS25005, AS33008, AS33009, AS33010, AS33011, AS37013, AS38014, AS38015, AS39016, AS39017, AS40018, AS44012, AT04001, AT04002, AT04003, AT04004, AT04005, AT22010, AT22011, AT22012, AT35013, AT35014, AT35015, AT35016, AT35017, AT35018, AT40019, AT40020, AT40021, AT40022, AT40023, AT40024, AT40025, AT40026, AT40027, AT40028, AT40029, AT40030, AT45031, AT45032, AT45033, AT45034, AT45035
  • 의료기기 분류등급
    Hematology and Pathology Devices
  • 의료기기 등급
    1
  • 이식된 장치?
    No
  • 유통
    Worldwide Distribution-USA (nationwide) including the states GA, NY, IL, TX, WA, PA, IN, MS, NC, and MO and the countries of Belgium, France, Hong Kong, Italy, Spain, and Switzerland.
  • 제품 설명
    UniCel DxH Slidemaker Stainer Stainer Floor Cabinet, PN A96152. || The DxH Slidemaker Stainer is a fully automated slide preparation and staining device that aspirates a whole blood-sample, smears a blood film on a clean microscope slide, and delivers a variety of fixatives, stains, buffers, and rinse solutions to that blood smear. The DxH Slidemaker Stainer allows for adaptation of the smear appearance and stain methodology according to user preferences. Blood smears produced by the Slidemaker portion of the DxH Slidemaker Stainer are moved to baskets for transfer to the Stainer portion by a robot arm. Microscopic examination of the stained blood smears can be used to help determine the hematologic status of a patient. A stained blood film: " Allows for the differentiation of white blood cells " Facilitates the characterization of red blood cells and platelets " Aids in the identification of blood components and cellular abnormalities The optional floor stand has four drawers for storing the reagent and waste containers currently in use in the DxH Slidemaker Stainer.
  • Manufacturer
    Beckman Coulter Inc.

Manufacturer

Beckman Coulter Inc.
  • 제조사 주소
    Beckman Coulter Inc., 250 S Kraemer Blvd, Brea CA 92821-6232
  • 제조사 모회사 (2017)
    Danaher Corporation
  • Source
    USFDA