Events

VITROS 5600 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
    60881
  • 사례 위험등급
    Class 3
  • 사례 연번
    Z-1073-2012
  • 사례 시작날짜
    2011-04-13
  • 사례 출판 날짜
    2012-02-21
  • 사례 상황
    Terminated
  • 사례 국가
    United States
  • 사례 종료 날짜
    2016-05-09
  • 사례 출처
    USFDA
  • 사례 출처 URL
    https://www.accessdata.fda.gov/scripts/cdrh/cfdocs/cfres/res.cfm?id=106705
  • 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 (ocd) received customer complaints regarding the loss of calibration data following the installation of a development assay data disk (add) that was available in the on-screen mailbox on the main menu system status screen of their vitros¿ 5600 integrated system. ocd's investigation determined that add, data release version (drv) 9241 or 9251 was electronically transferr.
  • 조치
    Ortho-Clinical Diagnostics (OCD) sent an Important Product Correction Notification letters dated April 13, 2011 via FedEx overnight to customers with an affected VITROS¿ 3600 or 5600 System (those not e-Connected). Foreign affiliate consignees were informed of this action via e-mail on April 13, 2011. The letters described the affected products, problem and actions to be followed. The letters states that an OCD Field Engineer will contact customers who has the affected products and perform a Modification (MOD) procedure that will remove ADD DRV 9241 or 9251 from the on-screen mailbox of their system(s). Customers were instructed to complete and return the accompanying Confirmation of Receipt Form and fax to1-888-557-3759 or 1-585-453-4110. The letter asks that distributors forward a copy of the enclosed customer communication to all customers who were shipped an affected VITROS¿ 3600 or 5600 System. For questions, please contact OCD's Customer Technical Services at 1-800-421-3311.

Device

VITROS 5600
  • 모델명 / 제조번호(시리얼번호)
    All VITROS¿ 5600 Systems Catalog # 6802413 that have not been eConnected which may have Assay Data Disk (ADD) Data Release Version (DRV) 9241 or 9251. J/Serial Numbers: 56000395, 56000482, 56000497,  56000511, 56000514, 56000524, 56000553, 56000607, 56000608, 56000770, 56000776, 56000777, 56000778, 56000824, 56000825, 56000826, 56000827, 56000835, 56000840, 56000841, 56000843, 56000888, 56000892, 56000902, 56000905, 56000927, 56000954, 56000955,  56000974, 56000976, 56000987, 56000990, 56000994, 56000122,  56000124, 56000133, 56000138, 56000187, 56000220, 56000223, 56000286, 56000288, 56000329, 56000353, 56000358, 56000429, 56000431, 56000455, 56000465, 56000487, 56000526, 56000627, 56000664, 56000672, 56000673, 56000674, 56000677, 56000683, 56000685, 56000715, 56000716, 56000723, 56000725, 56000726, 56000730, 56000732, 56000733, 56000734, 56000735, 56000739, 56000754, 56000760, 56000761, 56000762, 56000763, 56000765, 56000766, 56000767, 56000784, 56000789, 56000791, 56000799, 56000804, 56000805, 56000806, 56000807, 56000808, 56000809, 56000828, 56000829, 56000834, 56000862, 56000868, 56000869, 56000870, 56000897, 56000899, 56000916, 56000917, 56000922, 56000931, 56000940, 56000944, 56000946, 56000947, 56000949, 56000956, 56000960, 56000969, 56000986, 56000988, 56000989, 56000998, 56001003, 56001005, 56001006, 56001009, 56001014, 56001017, 56001018, 56001020, 56001030, 56001034, 56001035, 56001036, 56001037, 56001038, 56001039, 56001040, 56001044, 56001045, 56001050. --- NOTE: VITROS¿ 5600 that are e-Connected are not affected by this issue.
  • 의료기기 분류등급
    Clinical Chemistry and Clinical Toxicology Devices
  • 의료기기 등급
    1
  • 이식된 장치?
    No
  • 유통
    Worldwide Distribution - USA (nationwide) including the countries of: Brazil, Canada, Chile, China, England, France, Germany, India, Italy, Japan, Mexico, Singapore, Spain and Venezuela.
  • 제품 설명
    VITROS¿ 5600 Integrated Systems, Catalog # 6802413; COMMON/USUAL NAME: VITROS¿ 5600 --- NOTE: VITROS¿ 5600 that are e-Connected are not affected by this issue. || Product Usage: || For use in the in vitro quantitative, semi-quantitative, and qualitative measurement of a variety of analytes of clinical interest, using VITROS¿ Immunodiagnostic Products Reagents.
  • Manufacturer
    Ortho-Clinical Diagnostics

Manufacturer

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