Events

Device Recall VITROS Chemistry Products PHBR Slides 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
    60831
  • 사례 위험등급
    Class 2
  • 사례 연번
    Z-1117-2012
  • 사례 시작날짜
    2011-06-23
  • 사례 출판 날짜
    2012-02-28
  • 사례 상황
    Terminated
  • 사례 국가
    United States
  • 사례 종료 날짜
    2016-05-10
  • 사례 출처
    USFDA
  • 사례 출처 URL
    https://www.accessdata.fda.gov/scripts/cdrh/cfdocs/cfres/res.cfm?id=106599
  • 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, phenobarbital - Product Code DLZ
  • 원인
    Ortho clinical diagnostics (ocd) received customer complaints of intermittent imprecision, outliers, or shifts in control fluid values when using various lots of vitros¿ chemistry products phbr slides (phenobarbital) from coating 0053.
  • 조치
    Ortho Clinical Diagnostics sent an "URGENT PRODUCT CORRECTION NOTIFICATION" letter dated June 23, 2011 to all affected customers. The letter identifies the product, problem, and actions to be taken by the customers. The letter instructs customers to discontinue using and discard all remaining lots of the affected product. A Confirmation of Receipt Form was attached so customers may complete and return to the firm. The firm recommends that customers consult with their Laboratory Medical Director and requesting physician to resolve any concerns they may have regarding previously reported results. Contact Customer Technical Services at 1-800-421-3311 for questions regarding this notification.

Device

Device Recall VITROS Chemistry Products PHBR Slides
  • 모델명 / 제조번호(시리얼번호)
    Lot numbers: 2532-0053-4961 (exp. 2/01/12), 2532-0053-4984 (exp. 2/01/12), 2532-0053-4996 (exp. 3/01/12), 2532-0053-4997 (exp. 3/01/12), 2532-0053-0144 (exp. 3/01/12), 2532-0053-0149 (exp. 3/01/12), 2532-0053-0217 (exp. 3/01/12), 2532-0053-0615 (exp. 4/01/12), 2532-0053-0616 (exp. 4/01/12), 2532-0053-1472 (exp. 5/01/12), 2532-0053-1488 (exp. 5/01/12), 2532-0053-1489 (exp. 5/01/12), 2532-0053-1490 (exp. 5/01/12) [Note the four middle numbers (0053) of the above Lot #s constitute the Coating #].
  • 의료기기 분류등급
    Clinical Chemistry and Clinical Toxicology Devices
  • 의료기기 등급
    2
  • 이식된 장치?
    No
  • 유통
    Worldwide Distribution-USA (nationwide) including Puerto Rico and the countries of Australia, Bermuda, Brazil, Canada, Chile, China, Colombia, England, France, Germany, India, Italy, Japan, Mexico, Panama, Singapore, Spain and Venezuela.
  • 제품 설명
    VITROS¿ Chemistry Products PHBR Slides, REF 822 1384 || --- COMMON/USUAL NAME: VITROS PHBR (Phenobarbital) Slides --- Ortho-Clinical Diagnostics, Inc. Rochester, NY --- Ortho-Clinical Diagnostics High Wycombe, UK --- This is an in vitro diagnostic. || For in vitro diagnostic use only. VITROS¿ Chemistry Products PHBR Slides quantitatively measure Phenobarbital (PHBR) concentration in serum and plasma using VITROS 250/350/950 and 5,1 FS Chemistry Systems and the VITROS 5600 Integrated System.
  • Manufacturer
    Ortho-Clinical Diagnostics

Manufacturer

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