Events

Device Recall KIT cobas 4800 HPV AMP/DET 240T / 960T USIVD, CEIVD 의 리콜

U.S. Food and Drug Administration에 따르면, 해당 리콜 는 United States 에서 Roche Molecular Systems, Inc. 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
    66036
  • 사례 위험등급
    Class 2
  • 사례 연번
    Z-2173-2013
  • 사례 시작날짜
    2013-07-25
  • 사례 출판 날짜
    2013-09-10
  • 사례 상황
    Terminated
  • 사례 국가
    United States
  • 사례 종료 날짜
    2015-08-06
  • 사례 출처
    USFDA
  • 사례 출처 URL
    https://www.accessdata.fda.gov/scripts/cdrh/cfdocs/cfres/res.cfm?id=121300
  • 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
    Kit, dna detection, human papillomavirus - Product Code MAQ
  • 원인
    During an internal investigation, a formulation error that occurred was identified during the manufacture of the cobas¿ 4800 hpv master mix reagent that was packaged in four (4) cobas¿ 4800 amp/det kits, us- and ce-ivd (240 and 960 test kit configurations). examination of the batch production record of the material revealed there was an error in the tare weight used for the carboy during the fina.
  • 조치
    Roche Molecular Diagnostics sent an Urgent Medical Device Correction letter dated July 25, 2013, to all affected customers via UPS return receipt. The letter identified the product the problem and the action needed to be taken by the customer. Customers were instructed to: 1. Immediately discontinue use of the product lots listed above. 2. Discard affected product according to local guidelines. 3. To receive replacement inventory, complete the entire attached faxback form and fax it to 1-866-918-8741. 4. The faxback form must be completed and returned even if you do not have affected inventory. 5. File this Urgent Medical Device Correction (UMDC) for future reference. Please contact Roche Molecular Diagnostics Technical Support, 24 hours a day, seven days a week at 1-800-526-1247, if you have questions about the information contained in this UMDC.

Device

Device Recall KIT cobas 4800 HPV AMP/DET 240T / 960T USIVD, CEIVD
  • 모델명 / 제조번호(시리얼번호)
    US-IVD:  Material number 05232880190  Lot Number  R13814, R15785  CE-IVD:   Material Number: 05235898190 05235898190 05235901190 05235910190  Lot Number R15771, R15304
  • 의료기기 분류등급
    Immunology and Microbiology Devices
  • 의료기기 등급
    3
  • 이식된 장치?
    No
  • 유통
    Worldwide Distribution - USA (nationwide) including the countries of Austria, Australia, Belgium, Brazil, Czech Rep, Canada, Croatia, Columbia, Denmark, Dominican Republic, Germany, Ecuador, France, Japan, Greenland, Mexico, Italy, New Zealand, Netherlands, Peru, Norway, Singapore, Romania, South Africa, Spain, South Korea, Sweden, Switzerland and UK.
  • 제품 설명
    KIT cobas 4800 HPV AMP/DET 240T / 960T US-IVD, CE-IVD || Roche Molecular System, Inc. 1080 US highway 202 South Branchburg, NJ 08876 USA || Roche Diagnostics 9115 Hague Road Indianapolis, IN 46250-0457 USA || The cobas¿ HPV Test is a qualitative in vitro test for the detection of Human Papillomavirus in patient specimens. The test utilizes amplification of target DNA by the Polymerase Chain Reaction (PCR) and nucleic acid hybridization for the detection of 14 high-risk (HR) HPV types in a single analysis. The test specifically identifies types HPV16 and HPV18 while concurrently detecting the rest of the high risk types (31, 33, 35, 39, 45, 51, 52, 56, 58, 59, 66 and 68). The cobas¿ HPV Test is indicated: (a) To screen patients 21 years and older with ASC-US (Atypical squamous cells of undetermined significance) cervical cytology test results to determine the need for referral to colposcopy. (b) To be used in patients 21 years and older with ASC-US cervical cytology results, to assess the presence or absence of high-risk HPV genotypes 16 and 18. This information, together with the physicians assessment of cytology history, other risk factors, and professional guidelines, may be used to guide patient management. The results of this test are not intended to prevent women from proceeding to colposcopy. (c) In women 30 years and older, the cobas¿ HPV Test can be used with cervical cytology to adjunctively screen to assess the presence or absence of high risk HPV types. This information, together with the physicians assessment of cytology history, other risk factors, and professional guidelines, may be used to guide patient management. (d) In women 30 years and older, the cobas¿ HPV Test can be used to assess the presence or absence of HPV genotypes 16 and 18. This information, together with the physicians assessment of cytology history, other risk factors, and professional guidelines, may be used to guide patient management. Cervical specimens that may be tested with the cobas¿ HPV Test include the following liquid based collection media and collection device: " ThinPrep¿ Pap TestTM PreservCyt¿ Solution " Endocervical Brush/Spatula
  • Manufacturer
    Roche Molecular Systems, Inc.

Manufacturer

Roche Molecular Systems, Inc.
  • 제조사 주소
    Roche Molecular Systems, Inc., 1080 Us Highway 202 S, Branchburg NJ 08876-3733
  • 제조사 모회사 (2017)
    Roche Holding AG
  • Source
    USFDA