Events

Rappel de Device Recall MagNA Pure 24 System Pathogen Protocols

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
    79899
  • Classe de risque de l'événement
    Class 2
  • Numéro de l'événement
    Z-1956-2018
  • Date de mise en oeuvre de l'événement
    2018-05-02
  • Statut de l'événement
    Open, Classified
  • Pays de l'événement
    United States
  • Source de l'événement
    USFDA
  • URL de la source de l'événement
    https://www.accessdata.fda.gov/scripts/cdrh/cfdocs/cfres/res.cfm?id=163850
  • 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
    Clinical sample concentrator - Product Code JJH
  • Cause
    Cross-contamination of samples has been reported when running the existing protocol on the system with the rack-based purification run.
  • Action
    Customers were notified of the field action by letter on 4/27/18. The letter included the following required actions: " If you used the MagNA Pure 24 Pathogen 200 and/or Pathogen 1000 protocols to extract nucleic acids for an assay for a chronic infectious disease (e.g., Hepatitis C Virus), then suspected false positives should be evaluated further following local procedures and retested as necessary. " Complete the attached fax form and fax it to 1-844-861-6232 or email it to roche6612@stericycle.com. " File this Urgent Medical Device Correction (UMDC) for future reference.

Device

Device Recall MagNA Pure 24 System Pathogen Protocols
  • Modèle / numéro de série
    Device Identifier: 07613336106174
  • Classification du dispositif
    Clinical Chemistry and Clinical Toxicology Devices
  • Classe de dispositif
    1
  • Dispositif implanté ?
    No
  • Distribution
    Worldwide Distribution - US Nationwide in the states of: CA, GA, HI, IN, MD, ME, MI, MN, NC, NY, PA, VI, and WI. The products were distributed to the following foreign countries: Austria, Belgium, Brazil, Chile, China, Columbia, Costa Rica, Czech Republic, Denmark, France, Germany, Guatemala, Hong Kong, Hungary, India, Israel, Italy, Japan, Mexico, Netherlands, Norway, Poland, Singapore, Slovenia, South Africa, South Korea, Spain, Switzerland, Taiwan, UAE, United Kingdom, Vietnam.
  • Description du dispositif
    MagNA Pure 24 System, GMMI: 07290519001 || Product Usage: || The MagNA Pure 24 System is a fully automated clinical sample extractor. It extracts nucleic acids from various sample types, sample tubes, and volume inputs for multiple downstream applications. The main features of the system are : Scalable purification of 1 to 24 samples Primary/secondary tube handling Inventory and sample management via barcodes Efficient order management via host The MagNA Pure 24 System offers 4 run types: Purification (rack) run Purification (cartridge) run Post Elution run Sample transfer run
  • 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