Events

Device Recall Coulter PrepPlus 2 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
    77362
  • 사례 위험등급
    Class 2
  • 사례 연번
    Z-2690-2017
  • 사례 시작날짜
    2017-05-22
  • 사례 상황
    Open, Classified
  • 사례 국가
    United States
  • 사례 출처
    USFDA
  • 사례 출처 URL
    https://www.accessdata.fda.gov/scripts/cdrh/cfdocs/cfres/res.cfm?id=155842
  • 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
    Automated pipetting, diluting and specimen processing workstations for flow cytometric analysis - Product Code PER
  • 원인
    When samples are prepared using the prepplus or prepplus 2 sample preparation systems and then run on a flow cytometer, there is an imprecision in the absolute counts on only the first tube in a run.
  • 조치
    The recalling firm initiated their recall by letter disseminated via email on 05/22/2017. The letter requested the following actions be taken: 1. Insert an empty daughter tube in place of a patient sample as the first tube in the carousel that is programmed for the addition of Flow-Count Fluorospheres.  2. Refer to the COULTER PrepPlus Operators Guide / PrepPlus 2 Instructions for Use (IFU) for instructions on adding Flow-Count Fluorospheres to daughter tubes. 3. Review all results following the flow cytometer data review instructions referenced in the associated IFU. Beckman Coulter also requested the consignee share this information with their laboratory staff and retain this notification as part of their laboratory Quality System documentation. If the consignee forwarded any of the affected product(s) listed above to another laboratory, They were asked to provide them a copy of the letter.

Device

Device Recall Coulter PrepPlus 2
  • 모델명 / 제조번호(시리얼번호)
    All serial numbers currently in the field
  • 의료기기 분류등급
    Clinical Chemistry and Clinical Toxicology Devices
  • 의료기기 등급
    1
  • 이식된 장치?
    No
  • 유통
    Worldwide Distribution
  • 제품 설명
    Coulter PrepPlus 2, Part Number 378600, || Product Usage: || The COULTER PrepPlus 2, when used in combination with the COULTER TQPrep Workstation, is intended to prepare human whole blood for In Vitro Diagnostic (IVD) Use with cleared Beckman Coulter IVD applications on cleared Beckman Coulter flow cytometers (FC500, Navios and Navios EX). The COULTER PrepPlus 2 is a microprocessor-controlled pipetting and diluting system, designed for automating sample preparation or assay methods. It is capable of aspirating and dispensing liquid samples.
  • 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