Events

Device Recall VITROS 5,1 FS Chemistry System, VITROS 5,1 Refurbished, VITROS 4600 and 5600 Chemistry System 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
    65472
  • 사례 위험등급
    Class 2
  • 사례 연번
    Z-1948-2013
  • 사례 시작날짜
    2013-06-06
  • 사례 상황
    Terminated
  • 사례 국가
    United States
  • 사례 종료 날짜
    2018-05-17
  • 사례 출처
    USFDA
  • 사례 출처 URL
    https://www.accessdata.fda.gov/scripts/cdrh/cfdocs/cfres/res.cfm?id=119029
  • 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
    Analyzer, chemistry (photometric, discrete), for clinical use - Product Code JJE
  • 원인
    Ortho clinical diagnostics is recalling cm/rt wear pads which are a component in the cm/rt incubator due to becoming worn before their replacement.
  • 조치
    Ortho Clinical Diagnostics sent an Important Product Correction Notification letter dated June 6, 2013 via FedEx to affected customers. The letter identified the affected product, problem and actions to be taken. Customers were informed that an OCD trained service personnel will contact them and schedule a replacement of the CM/RT wear pads. OCD requested customers to complete and return the enclosed Confirmation of Receipt form no later than June 17, 2013. Customers are asked to place a copy of the notification by each VITROS System in their facility. Foreign affiliates were notified by email on June 6, 2013 of the issue and instructed to notify their consignees of the issue and actions. If you have any questions or need additional information, please call Customer Technical Services at 1-800-421-3311.

Device

Device Recall VITROS 5,1 FS Chemistry System, VITROS 5,1 Refurbished, VITROS 4600 and 5600 Chemi...
  • 모델명 / 제조번호(시리얼번호)
    Serial Numbers: 1) J34000102 through J34002323, 2) 34000133, 34000193, 4000212, 34000316, 34000318, 34000337, 34000360, 34000420, 34000451, 34000478, 34000495, 34000497, 34000529, 34000538, 34000552, 34000557,  34000596, 34000601, 34000631, 34000642, 34000805, 34000833, 34000851, 34000893, 34000947, 34001172, 34001218, 34001240, 34001243, 34001248, 34001251, 34001274, 34001297, 34001311, 34001317, 34001345, 34001378, 34001389, 34001390, 34001396, 34001422, 34001472, 34001504, 34001569, 34001572, 34001589, 34001610, 34001612, 34001633, 34001668, 34001809,  34001840, 34001850, 34001897, 3) J46000108 through J46000312, 4) J56000110 through J56001779.
  • 의료기기 분류등급
    Clinical Chemistry and Clinical Toxicology Devices
  • 의료기기 등급
    1
  • 이식된 장치?
    No
  • 유통
    Worldwide Distribution - USA Nationwide in the states of AK, AL, AR, AZ, CA, CO, CT, DC, DE, FL, GA, HI, IA, ID, IL, IN, KS, KY, LA, MA, MD, ME, MI, MN, MO, MS, MT, NC, NE, NH, NJ, NM, NV, NY, OH, OK, OR, PA, SC, SD, TN, TX, UT, VA, VT, WA, WI, WV, WY, including Puerto Rico and the countries of Mexico, Singapore, Venezuela, England, Germany, Italy & Spain.
  • 제품 설명
    Colorimetric (CM)/ Rate (RT) incubator wear pads. Product Codes: 1) 6801375, 2) 6801890, 3) 6802445, 4) 6802413 || Product Usage: The CM/RT incubator processes Microslide reagents with the following VITROS systems: 1) VITROS 5,1 FS Chemistry System, 2) VITROS 5,1 FS Chemistry System Refurbished, 3) VITROS 4600 Chemistry System (VITROS 5,1 FS System family member), VITROS 5600 Integrated System.
  • Manufacturer
    Ortho-Clinical Diagnostics

Manufacturer

Ortho-Clinical Diagnostics
  • 제조사 주소
    Ortho-Clinical Diagnostics, 100 Indigo Creek Dr, Rochester NY 14626-5101
  • 제조사 모회사 (2017)
    The Carlyle Group LP
  • Source
    USFDA