Events

VARIANT(tm) nbs Sickle Cell Prograin 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
    55910
  • 사례 위험등급
    Class 3
  • 사례 연번
    Z-1984-2011
  • 사례 시작날짜
    2010-04-14
  • 사례 출판 날짜
    2011-04-14
  • 사례 상황
    Terminated
  • 사례 국가
    United States
  • 사례 종료 날짜
    2011-08-08
  • 사례 출처
    USFDA
  • 사례 출처 URL
    https://www.accessdata.fda.gov/scripts/cdrh/cfdocs/cfres/res.cfm?id=92218
  • 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
    Abnormal hemoglobin quantitation - Product Code GKA
  • 원인
    The affected resin update cd-roms cause all user-defined settings in the setup/test/data setup sub screen and set/test/pattern setting sub screen to be overwritten when the update kit procedure is performed.
  • 조치
    Bio-Rad Laboratories sent out the Urgent Medical Device Correction notice on 4/14/2011, by Federal Express. An Update was sent on May 13th, advising customers of a minor discrepancy in the parameters included on the affected Resin Update CD-ROMs. Customers were instructed to examine your inventory for the affected reorder pack lots. Please complete and return the Medical Device Correction Response Form Questions regarding this recall please call (510) 724-6114.

Device

VARIANT(tm) nbs Sickle Cell Prograin Reorder Pack.
  • 모델명 / 제조번호(시리얼번호)
    Resin Update CD-ROM, 250-3020 lot # AA 00092 goes with Reorder Pack Lot No. 50392618 Resin Update CD-ROM, 250-3020 lot # BA 00092 goes with Reorder Pack Lot No 50300210.  Resin Update CD-ROM, 250-3020 lot # CA 00092  Reorder Pack Lot No 50300645 & 50300650. Expiration date: 05/31/2011, 06/30/2011, 08/31/2011 PIN No. 250-3000;
  • 의료기기 분류등급
    Hematology and Pathology Devices
  • 의료기기 등급
    2
  • 이식된 장치?
    No
  • 유통
    Worldwide Distribution -- USA , Brazil, Canada, Caribbean, France, Italy, and United Kingdom.
  • 제품 설명
    VARIANT nbs Sickle Program Resin Update CD-ROM; Model Number:250-3020, included in 250-3000; Distributed and Manufactured by Bio-Rad Laboratories, Inc. The VARIANT nbs Sickle Cell Program is intended as a qualitative screen for the presence of hemoglobins F, A, S, D, C and E in eluates of neonatal blood collected on filter paper by high-performance liquid chromatography(HPLC). The VARIANT nbs Sickle Cell Program is intended for Professional use only.
  • Manufacturer
    Bio-Rad Laboratories Inc

Manufacturer

Bio-Rad Laboratories Inc
  • 제조사 주소
    Bio-Rad Laboratories Inc, 4000 Alfred Nobel Dr, Hercules CA 94547-1803
  • Source
    USFDA