Device Recall VITROS Chemistry Products CDM PROM 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
    67509
  • 사례 위험등급
    Class 2
  • 사례 연번
    Z-1490-2014
  • 사례 시작날짜
    2014-01-29
  • 사례 출판 날짜
    2014-04-23
  • 사례 상황
    Terminated
  • 사례 국가
  • 사례 종료 날짜
    2018-05-18
  • 사례 출처
    USFDA
  • 사례 출처 URL
  • 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
    Enzymatic method, creatinine - Product Code JFY
  • 원인
    Customers were unable to calibrate, or use previously calibrated, vitros dt crsc slides (ref/product code 6802721), gen 82, on the vitros dt ii system, when using calibration data module (cdm) rev. 168 (ref/product code 199 9077), as cdm 168 does not contain calibration parameters for dt crsc.
  • 조치
    Ortho Clinical Diagnostics sent an Urgent Product Correction Notification Letters dated January 29, 2014, via FedEx overnight courier and/or US Postal Service Priority Mail (for PO Boxes only) to US consignees to inform them of the issue. Customers were advised to Inspect their inventory to determine if they had VITROS CRSC DT Slides, GEN 82. - To use their current inventory of GEN 82 until the replacement order arrives providing that they have CDM PROM 0167 installed on their system and calibrate using VITROS DT Calibrator Kit, Lot 42. - If product replacement is required, discard their remaining inventory of VITROS CRSC DT Slides, GEN 82 upon receipt of their replacement order. - Complete and return the Confirmation of Receipt Form by February 7, 2014, by fax to 1-888-557-3759 or 1-585-453-04110, or email to: ConfirmationAdmin@its.jnj.com. Indicate on the form if they have any inventory of the affected lot that will require replacement. - Forward this information if they have distributed this product outside of your facility. Distributors were also instructed to identify all customers and any other branches who were shipped VITROS CRSC DT Slides, GEN 82 from their facility and send a copy of the Urgent Product Correction Notification Letter to inform them of the issue. Foreign affiliates were informed by e-mail on January 22, 2014, of the issue and instructed to notify their consignees of the issue and required actions.

Device

  • 모델명 / 제조번호(시리얼번호)
    Calibration Data Module Rev. 0168, REF 199 9077 used in conjuction with of VITROS Chemistry Products CRSC DT Slides, Generation (GEN) 82, Product Code 6802721.
  • 의료기기 분류등급
  • 의료기기 등급
    2
  • 이식된 장치?
    No
  • 유통
    Worldwide Distribution - US Distribution including the states of AR, FL, IA, IL, KY, MI, MN, ND, NY and VA, and the countries of Australia, Brazil, Canada, Chile, China, Colombia, England, France, Germany, India, Italy, Japan, Mexico, Panama, Singapore, Spain, and Venezuela.
  • 제품 설명
    VITROS Chemistry Products CDM PROM (Calibration Data Module) No. 0168, Catalog Number/REF 199 9077, used in conjunction with: VITROS Chemistry Products CRSC DT Slides, Generation (GEN) 82, REF 6802721, and || VITROS DT Calibrator Kit, Product Code 1957924, and tested on the VITROS DT60/DT60 II Chemistry System; IVD --- Ortho-Clinical Diagnostics, Inc.
  • Manufacturer

Manufacturer

  • 제조사 주소
    Ortho-Clinical Diagnostics, 1000 Lee Road, Rochester NY 14606
  • 제조사 모회사 (2017)
  • Source
    USFDA