Events

Boule ConDiff Hematology Control 의 리콜

U.S. Food and Drug Administration에 따르면, 해당 리콜 는 United States 에서 Clinical Diagnostic Solutions 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
    63094
  • 사례 위험등급
    Class 3
  • 사례 연번
    Z-0193-2013
  • 사례 시작날짜
    2010-08-04
  • 사례 출판 날짜
    2012-11-05
  • 사례 상황
    Terminated
  • 사례 국가
    United States
  • 사례 종료 날짜
    2014-08-14
  • 사례 출처
    USFDA
  • 사례 출처 URL
    https://www.accessdata.fda.gov/scripts/cdrh/cfdocs/cfres/res.cfm?id=112532
  • 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
    Mixture, hematology quality control - Product Code JPK
  • 원인
    Clinical diagnostic solutions, inc. in plantation, fl recalled the boule con diff us tri pack (product part 501-605, lot #1005-549 and product part 501-607, lot #1005-549) which is used for in vitro diagnostic use as a control to monitor the performance of multi-parameter hematology instruments. the recall was imitated due to receipt of customers stating the mcv values and rdw% recovered for boule.
  • 조치
    Clinical Diagnostic Solutions, Inc. sent a "PRODUCT NOTIFICATION:BOULE CON DIFF TRI-LEVEL LOT 1005-549" letter dated August 4, 2010 to all affected customers. The letter identified the product, problem, and actions to be taken by the customers. For questions regarding this notice, contact CDS Customer Service at 1-800-453-3328.

Device

Boule ConDiff Hematology Control
  • 모델명 / 제조번호(시리얼번호)
    Product part 501-605, Lot #1005-549
  • 의료기기 분류등급
    Hematology and Pathology Devices
  • 의료기기 등급
    2
  • 이식된 장치?
    No
  • 유통
    Nationwide Distribution.
  • 제품 설명
    Boule Con Diff US Tri Pack, 6 Vials. || For in vitro diagnostic use as a control to monitor the performance of multi-parameter hematology instruments.
  • Manufacturer
    Clinical Diagnostic Solutions

Manufacturer

Clinical Diagnostic Solutions
  • 제조사 주소
    Clinical Diagnostic Solutions, 1800 Nw 65th Ave Ste 2, Plantation FL 33313-4544
  • 제조사 모회사 (2017)
    Boule Diagnostics AB
  • Source
    USFDA