Events

IDS 25Hydroxy Vitamin D EIA Enzymeimmunoassay 의 리콜

U.S. Food and Drug Administration에 따르면, 해당 리콜 는 United States 에서 Immunodiagnostics Systems 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
    49393
  • 사례 위험등급
    Class 3
  • 사례 연번
    Z-0173-2009
  • 사례 시작날짜
    2008-08-02
  • 사례 출판 날짜
    2008-10-24
  • 사례 상황
    Terminated
  • 사례 국가
    United States
  • 사례 종료 날짜
    2012-08-13
  • 사례 출처
    USFDA
  • 사례 출처 URL
    https://www.accessdata.fda.gov/scripts/cdrh/cfdocs/cfres/res.cfm?id=73245
  • 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
    Vitamin D test system - Product Code MRG
  • 원인
    A small number of customers have experienced low absorbance values when using kits from this batch.
  • 조치
    All customers who received 25-Hydroxy Vitamin D EIA lot # 60897 were contacted by mail. Customers were instructed to sign a confirming document for having received the notification letter and return via fax. Customers are requested to contact Immunodiagnostic System Inc's office if they have any kits of 60897 remaining in stock. Rather than replacing only the biotin buffer as stated in the letter dated August 2, 2008, Immunodiagnostic Systems Inc. will replace the kit per the letter dated August 8, 2008. Contact Immunodiagnostic System Inc. at 1-480-836-7435 for assistance.

Device

IDS 25Hydroxy Vitamin D EIA Enzymeimmunoassay
  • 모델명 / 제조번호(시리얼번호)
    Lot Code #60897
  • 의료기기 분류등급
    Clinical Chemistry and Clinical Toxicology Devices
  • 의료기기 등급
    2
  • 이식된 장치?
    No
  • 유통
    Nationwide
  • 제품 설명
    IDS 25-Hydroxy Vitamin D EIA Enzymeimmunoassay for the quantitative determination of 25-hydroxyvitamin D and other hydroxylated metabolites in serum or plasma. Ref: AC-57F1 Lot 60897 Exp 2009-08; Immunodiagnostic Systems Ltd, Unit 10, Boldon Business Park, Boldon, Tyne & Wear, NE35. 9PD, UK. Enzymeimmunoassay for the quantitative determination of 25-hydroxyvitamin D and other hydroxylated metabolites in serum or plasma
  • Manufacturer
    Immunodiagnostics Systems Inc

Manufacturer

Immunodiagnostics Systems Inc
  • 제조사 주소
    Immunodiagnostics Systems Inc, 17029 E Enterprise Dr Ste 1, Fountain Hills AZ 85268
  • Source
    USFDA