Events

Rappel de MagNA Pure LC 2.0 Instrument

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 Diagnostics Operations, 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
    57534
  • Classe de risque de l'événement
    Class 2
  • Numéro de l'événement
    Z-1651-2011
  • Date de mise en oeuvre de l'événement
    2010-10-26
  • Date de publication de l'événement
    2011-03-14
  • Statut de l'événement
    Terminated
  • Pays de l'événement
    United States
  • Date de fin de l'événement
    2011-08-30
  • Source de l'événement
    USFDA
  • URL de la source de l'événement
    https://www.accessdata.fda.gov/scripts/cdrh/cfdocs/cfres/res.cfm?id=96478
  • 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
    Real time nucleic acid amplification system - Product Code OOI
  • Cause
    If the bar code is printed from the batch results screen, a wrong batch id may be printed, while the correct batch id is still assigned to the batch in the data repository of the mplc 2.0 software. this may result in sample mis identification. if printed from the ordering screens, the bar code is printed with the correct batch id.
  • Action
    The firm, Roche, sent an "URGENT MEDICAL DEVICE CORRECTION" letter dated November 04, 2010 to its customers. The letter described the product, problem and action to be taken. The customers were instructed to print batch ID barcode labels from the ordering or stage set up screens only; print Cooling Block barcode labels from the Post Elution Edit screen only; complete and return the attached UMDC Faxback Form for MagNA Pure LC 2.0 Instrument [UMDC 10-228] via fax to 1-877-551-7152 and file this correction notice for future reference. The firm plans to issue a software update in first quarter 2011. If you have questions about the information contained in this UMDC, for Clinical customers, please contact Roche Molecular Diagnostics Technical Service at 1-800-526-1247; for Research customers, please contact Roche Applied Sciences Technical Service at 1-800-262-4911.

Device

MagNA Pure LC 2.0 Instrument
  • Modèle / numéro de série
    LC2C00000032, LC2C00000033, LC2C00000035, LC2C00000060, LC2C00000064, LC2C00000079, LC2C00000080, LC2C00000081, LC2C00000108, LC2C00000110, LC2C00000118, LC2C00000119, LC2C00000120, LC2C00000127, LC2C00000128, LC2C00000130, LC2C00000131, LC2C00000132, LC2C00000133, LC2C00000134, LC2C00000155, LC2C00000156, LC2C00000158, LC2C00000159, LC2C00000162, LC2C00000168, LC2C00000169, LC2C00000170, LC2C00000172, LC2C00000173, LC2C00000178, LC2C00000179, LC2C00000180, LC2C00000192, LC2C00000193, LC2C00000195, LC2C00000196, LC2C00000203, LC2C00000204, LC2C00000205, LC2C00000206, LC2C00000212, LC2C00000213, LC2C00000214, LC2C00000215, LC2C00000216, LC2C00000217, LC2C00000218, LC2C00000219, LC2C00000220, LC2C00000227, LC2C00000228, LC2C00000232, LC2C00000233, LC2C00000234, LC2C00000235, LC2C00000236, LC2C00000242, LC2C00000243, LC2C00000244, LC2C00000250, LC2C00000252, LC2C00000253, LC2C00000254, LC2C00000255, LC2C00000256, LC2C00000263, LC2C00000264, LC2C00000265, LC2C00000266, LC2C00000267, LC2C00000268, LC2C00000269, LC2C00000270, LC2C00000272, LC2C00000273, LC2C00000274, LC2C00000275, LC2C00000276, LC2C00000293, LC2C00000294, LC2C00000298, LC2C00000309, LC2C00000310, LC2C00000312, LC2C00000313, LC2C00000314, LC2C00000329, LC2C00000330, LC2C00000331, LC2C00000358, LC2C00000359, LC2C00000360, LC2C00000361, LC2C00000363, LC2C00000364, LC2C00000381, LC2C00000384, LC2C00000392, LC2C00000393, LC2C00000394, LC2C00000412, LC2C00000413, LC2C00000414, LC2C00000415, LC2C00000418, LC2C00000419, LC2C00000420, LC2C00000427, LC2C00000429, LC2C00000430, LC2C00000431, LC2C00000449, LC2C00000479, LC2C00000483, LC2C00000486, LC2C00000563, LC2C00000571 and LC2C00000578.
  • Classification du dispositif
    Clinical Chemistry and Clinical Toxicology Devices
  • Classe de dispositif
    2
  • Dispositif implanté ?
    No
  • Distribution
    Worldwide distribution: AL, AZ, CA, CO, DC, FL, GA, HI, IL, KY, LA, MA, MD, ME, MN, MO, MT, NC, ND NE, NH, NJ, NM, NY, OH, OK, OR, SC, SD, TN, TX, UT, VA, VT, WI and Puerto Rico; and country of Europe.
  • Description du dispositif
    MagNA Pure LC 2.0 Instrument, catalog number 05197686001, Roche Diagnostics, Indianapolis, IN || MagNA Pure LC 2.0 instrument is a robotic instrument for automated isolation of nucleic acids (DNA, total RNA , total viral nucleic acids) from different kinds of biological research sample material (whole blood, serum, blood cells, culture cells, tissue, bacteria, fungi) using the specially designed MagNA Pure LC kits, for the purpose of life science research only and automated filling of different kinds of PCR reaction vessels (LightCycler Capillaries, 96 well PCR plates, PCR tube strips) with PCR reaction mixes and template nucleic acid, or other reaction tubes for making of dilution series, reaction mixes.
  • Manufacturer
    Roche Diagnostics Operations, Inc.

Manufacturer

Roche Diagnostics Operations, Inc.
  • Adresse du fabricant
    Roche Diagnostics Operations, Inc., 9115 Hague Road, Indianapolis IN 46256-1025
  • Société-mère du fabricant (2017)
    Roche Holding AG
  • Source
    USFDA