Events

Rappel de Device Recall KIT cobas 4800 HPV AMP/DET 240T / 960T USIVD, CEIVD

Selon U.S. Food and Drug Administration, ce/cet/cette rappel concerne un dispositif en/au/aux/à United States qui a été fabriqué par Roche Molecular Systems, Inc..

Qu'est-ce que c'est?

Une correction ou un retrait opéré par un fabricant afin de répondre à un problème causé par un dispositif médical. Les rappels surviennent lorsqu'un dispositif médical est défectueux, lorsqu'il pourrait poser un risque pour la santé, ou les deux à la fois.

En savoir plus sur les données ici
  • Type d'événement
    Recall
  • ID de l'événement
    66036
  • Classe de risque de l'événement
    Class 2
  • Numéro de l'événement
    Z-2173-2013
  • Date de mise en oeuvre de l'événement
    2013-07-25
  • Date de publication de l'événement
    2013-09-10
  • Statut de l'événement
    Terminated
  • Pays de l'événement
    United States
  • Date de fin de l'événement
    2015-08-06
  • Source de l'événement
    USFDA
  • URL de la source de l'événement
    https://www.accessdata.fda.gov/scripts/cdrh/cfdocs/cfres/res.cfm?id=121300
  • Notes / Alertes
    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.
  • Notes supplémentaires dans les données
    Kit, dna detection, human papillomavirus - Product Code MAQ
  • Cause
    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.
  • Action
    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
  • Modèle / numéro de série
    US-IVD:  Material number 05232880190  Lot Number  R13814, R15785  CE-IVD:   Material Number: 05235898190 05235898190 05235901190 05235910190  Lot Number R15771, R15304
  • Classification du dispositif
    Immunology and Microbiology Devices
  • Classe de dispositif
    3
  • Dispositif implanté ?
    No
  • Distribution
    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.
  • Description du dispositif
    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.
  • Adresse du fabricant
    Roche Molecular Systems, Inc., 1080 Us Highway 202 S, Branchburg NJ 08876-3733
  • Société-mère du fabricant (2017)
    Roche Holding AG
  • Source
    USFDA