Events

Device Recall VITROS Valproic Acid (VALP) Reagent 의 리콜

U.S. Food and Drug Administration에 따르면, 해당 리콜 는 United States 에서 Ortho-Clinical Diagnostics 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
    60800
  • 사례 위험등급
    Class 2
  • 사례 연번
    Z-0984-2012
  • 사례 시작날짜
    2011-05-10
  • 사례 출판 날짜
    2012-02-08
  • 사례 상황
    Terminated
  • 사례 국가
    United States
  • 사례 종료 날짜
    2016-02-12
  • 사례 출처
    USFDA
  • 사례 출처 URL
    https://www.accessdata.fda.gov/scripts/cdrh/cfdocs/cfres/res.cfm?id=106564
  • 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, valproic acid - Product Code LEG
  • 원인
    Results using vitros¿ chemistry products valp reagent were negatively biased compared to other manufacturers. ocd confirmed that patient results were also affected by this issue.
  • 조치
    All domestic end-user consignees were initially sent "Important Product Correction Notification" recall communications (dated 5/10/11) by Federal Express overnight mail on 5/10/11. The letters informed users of the issue, and advised them to discontinue using their VITROS VALP reagent until adjusted calibrator values are provided for GEN 14 of VITROS VALP Reagent. The adjusted calibrator values for VITROS VALP Reagent were sent to customers via Assay Data Disk (ADD) Data Release Version (DRV) 5632. Customers were to refer to the Technical Support Communication for details. Users were to confirm receipt of the notice by completing and returning the Fax Reply Form - Confirmation; confirm that all customers or distributors were informed of the issue and instructed to discontinue use of affected product; and lastly confirm that all customers or distributors were sent adjusted calibrator values.

Device

Device Recall VITROS Valproic Acid (VALP) Reagent
  • 모델명 / 제조번호(시리얼번호)
    Reagent Lots from Generation (GEN) 14: 1511-14-9637 (exp. 6/30/11), 1511-14-9776 (exp. 9/30/11), 1511-14-9894 (exp. 11/30/11), 1511-14-1094 (exp. 1/31/12), and 1511-14-1230 (exp. 4/30/12).
  • 의료기기 분류등급
    Clinical Chemistry and Clinical Toxicology Devices
  • 의료기기 등급
    2
  • 이식된 장치?
    No
  • 유통
    Worldwide Distribution -- US, Bermuda, Brazil, Canada, Chile, China, Colombia, England, France, Germany, India, Italy, Japan, Mexico, Panama, Singapore, Spain, and Venezuela.
  • 제품 설명
    VITROS¿ Valproic Acid (VALP) Reagent, REF/Catalog No. 6801710 --- Ortho- Clinical Diagnostics Rochester, NY USA -- Ortho- Clinical Diagnostics High Wycombe, UK --- An in vitro diagnostic. || For in vitro diagnostic use only. Used to quantitatively measure valproic acid (VALP) concentration in human serum and plasma.
  • Manufacturer
    Ortho-Clinical Diagnostics

Manufacturer

Ortho-Clinical Diagnostics
  • 제조사 주소
    Ortho-Clinical Diagnostics, 100 Indigo Creek Drive, Rochester NY 14626
  • Source
    USFDA