Events

Synchron Phenobarbital (PHE) Drug Calibrator 1 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
    60937
  • 사례 위험등급
    Class 2
  • 사례 연번
    Z-1173-2012
  • 사례 시작날짜
    2009-08-11
  • 사례 출판 날짜
    2012-03-06
  • 사례 상황
    Terminated
  • 사례 국가
    United States
  • 사례 종료 날짜
    2013-12-05
  • 사례 출처
    USFDA
  • 사례 출처 URL
    https://www.accessdata.fda.gov/scripts/cdrh/cfdocs/cfres/res.cfm?id=106837
  • 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
    Enzyme immunoassay, phenobarbital - Product Code DLZ
  • 원인
    The recall was initiated because beckman coulter has confirmed reports of variability in results with the lots of phenobarbital (phe) reagent and calibrator.
  • 조치
    Beckman Coulter sent an "URGENT: PRODUCT CORRECTIVE ACTION" letter dated August 26, 2009 to all customers. The letter identifies the product, problem, and actions to be taken by the customers. Customers were instructed to share the recall information with their laboratory staff and retain this notification as part of their laboratory Quality System documentation. Customers were asked to complete and return a response form. Contact Beckman Coulter Customer Support Center (Hotline) at (800) 854-3633 for questions regarding this recall.

Device

Synchron Phenobarbital (PHE) Drug Calibrator 1
  • 모델명 / 제조번호(시리얼번호)
    M810440 and earlier
  • 의료기기 분류등급
    Clinical Chemistry and Clinical Toxicology Devices
  • 의료기기 등급
    2
  • 이식된 장치?
    No
  • 유통
    Worldwide Distribution--USA (nationwide) and the country of Canada.
  • 제품 설명
    Synchron Phenobarbital (PHE) Drug Calibrator 1, P/N 469600, || Classification Product Code: KLT. || Subsequent Product Codes: DIP, KLS, LCD, LCQ, LCR, LFN. || The Beckman Coulter SYNCHRON Systems DRUG CALIBRATOR 1, when used in conjunction with SYNCHRON reagents, is intended for use on the SYNCHRON Systems for the calibration of Carbamazepine, Phenobarbital, Phenytoin, Theophylline, and Valproic Acid.
  • 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