Events

VARIANT II Link Hemoglobin A1c Program Reorder Pack 의 리콜

U.S. Food and Drug Administration에 따르면, 해당 리콜 는 United States 에서 Bio-Rad Laboratories, 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
    60230
  • 사례 위험등급
    Class 3
  • 사례 연번
    Z-0399-2012
  • 사례 시작날짜
    2011-10-25
  • 사례 출판 날짜
    2012-01-11
  • 사례 상황
    Terminated
  • 사례 국가
    United States
  • 사례 종료 날짜
    2012-02-02
  • 사례 출처
    USFDA
  • 사례 출처 URL
    https://www.accessdata.fda.gov/scripts/cdrh/cfdocs/cfres/res.cfm?id=104832
  • 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
    Calibrator, hemoglobin and hematocrit measurement - Product Code KRZ
  • 원인
    It was discovered that the variant ii turbo link calibrator values card contains incorrect values for ifcc units. the numbers are missing a decimal point.
  • 조치
    Bio-Rad Laboratories, Inc. sent a Medical Device Correction Notification letter dated October 25, 2011, via Federal Express to all affected customers. The letter identified the product, the problem, and the action to be taken by the customer. The correction was initiated by the firm, customers were instructed to contact their regional Bio-Rad office for any questions. For questions regarding this recall call 510-741-6114.

Device

VARIANT II Link Hemoglobin A1c Program Reorder Pack
  • 모델명 / 제조번호(시리얼번호)
    Catalog number: 270-2716: Lot 70211322; 70211432, 70211440; exp 3/31/2012
  • 의료기기 분류등급
    Hematology and Pathology Devices
  • 의료기기 등급
    2
  • 이식된 장치?
    No
  • 유통
    Nationwide Distribution including MI, SC, OH, IL, MN, MD, VA, NY and WI.
  • 제품 설명
    VARIANT II Link Hemoglobin A1c Program Reorder Pack, || 1600 tests, IVD, For the determination of Hemoglobin A1c in human whole blood. || Contents: || Elution Buffer A , 1 x 2500 mL || Elution Buffer B, 1 x 2100 mL || Wash/Diluent Solution, 1 x 2500 mL || Cartridge Set || CD ROM - 1 || Calibrator/Diluent Set || Whole Blood Primer, 6 x 1 mL || Sample vials, 2 x 100 || Instruction Manual || Bio-Rad Laboratories, Inc., 400 Alfred nobel Drive, Hercules, CA 94547-1803. || Intended for the percent determination of hemoglobin A1c in human whole blood using ion-exchange high-performance liquid chromatography (HLCP).
  • Manufacturer
    Bio-Rad Laboratories, Inc.

Manufacturer

Bio-Rad Laboratories, Inc.
  • 제조사 주소
    Bio-Rad Laboratories, Inc., 4000 Alfred Nobel Drive, Hercules CA 94547-1803
  • 제조사 모회사 (2017)
    Bio-Rad Laboratories Inc
  • Source
    USFDA