Events

Device Recall BioPlex 2200 EBV IgG Calibrator Set. 의 리콜

U.S. Food and Drug Administration에 따르면, 해당 리콜 는 United States 에서 Bio-Rad Laboratories 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
    58291
  • 사례 위험등급
    Class 2
  • 사례 연번
    Z-2082-2011
  • 사례 시작날짜
    2011-03-11
  • 사례 출판 날짜
    2011-04-27
  • 사례 상황
    Terminated
  • 사례 국가
    United States
  • 사례 종료 날짜
    2011-12-22
  • 사례 출처
    USFDA
  • 사례 출처 URL
    https://www.accessdata.fda.gov/scripts/cdrh/cfdocs/cfres/res.cfm?id=98905
  • 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
    Epstein-barr virus, other - Product Code LSE
  • 원인
    Bio-rad laboratories confirmed a downward shift in control values for ebv na-1 analyte when using the bioplex 2200 ebv igg calibrator set lot #46704.
  • 조치
    The firm, Bio-Rad Laboratories, sent an "Voluntary Field Correction: BioPlex 2200 EBV IgG Calibrator Set, Lot# 46704 for EBV NA-1 Analyte" letter dated March 16, 2011 domestic customers via Fed-Ex and and to international subsidiaries via e-mail. The letter described the product, problem and actions to be taken. The consignees/customers were informed that Bio-Rad confirmed downward shift in control values for the EBV NA-1 analyte when using the BioPlex 2200 EBV IgG Calibrator Set, Lot # 46704. If this occurs, the customers were instructed to readjust the positive control mean using the procedure presented in the customer notification "BioPlex 2200 Quality Control Values (L60013402)". If the re-adjusted mean of the EBV NA-1 controls is within the manufacturer's limit, patient results may be reported. If the new assay positive control mean still does not fall within the manufacturer's limit, the customers were instructed to contact their local Bio-Rad Technical Support and do not report the EBV NA-1 values. The customers were also instructed to complete and return the CUSTOMER RESPONSE FORM via fax to 510-741-5775. If the BioPlex 2200 EBV VCA IgG and EBV EA-D IgG positive and negative control means are within the acceptable QC range, and subsequent passing QC runs are obtained, patient results may be reported for these analytes. Bio-Rad will be manufacturing a new lot of the BioPlex 2200 EBV IgG Calibrator Set which will bring the control values within the manufacturer's limit. It may be necessary to readjust the QC ranges after the consignees receive this new calibrator set lot. Bio-Rad will send their consignees/customers the replacement calibrators and calibrator CDs when available. The consignees/customers were also instructed to discard the calibrator set lot# 46704 in accordance with national and/or local regulations. Customers can call Clinical Diagnostics Group at 510-741-4431 or email to BPD-ProductSupport@bio-rad.com for any questions

Device

Device Recall BioPlex 2200 EBV IgG Calibrator Set.
  • 모델명 / 제조번호(시리얼번호)
    Lot #46704.
  • 의료기기 분류등급
    Immunology and Microbiology Devices
  • 의료기기 등급
    1
  • 이식된 장치?
    No
  • 유통
    Worldwide distribution: USA including the following states: AL, AZ, CA, CT, FL, GA, HI, IL, IN, LA, MA, MD, MI, MN, NC, NJ, NY, OH, OR, PA, TN, TX, VA, WA, and WI; and countries of: Australia, Czech Republic, France, Germany, Italy and Republic of Korea.
  • 제품 설명
    BioPlex 2200 EBV IgG Calibrator Set. Catalog #663-1200. || Product is labeled in part: "BIO-RAD***BioPlex 2200 EBV IgG Calibrator Set***7 x 0.5 mL***A Calibrator set for the BioPlex 2200 EBV IgG Reagent Pack***UNITED STATES, Bio-Rad Laboratories, Inc., Hercules, CA 94547". || BioPlex 2200 EBV IgG Calibrator Set is intended for the calibration of the BioPlex 2200 EBV IgG Reagent Pack.
  • Manufacturer
    Bio-Rad Laboratories

Manufacturer

Bio-Rad Laboratories
  • 제조사 주소
    Bio-Rad Laboratories, 6565 185th Ave NE, Redmond WA 98052-5039
  • 제조사 모회사 (2017)
    Bio-Rad Laboratories Inc
  • Source
    USFDA