Events

Rappel de Device Recall BD BACTEC(tm) MGIT (tm) 960 System

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 Becton Dickinson & Co..

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
    59036
  • Classe de risque de l'événement
    Class 2
  • Numéro de l'événement
    Z-2890-2011
  • Date de mise en oeuvre de l'événement
    2011-03-28
  • Date de publication de l'événement
    2011-07-28
  • Statut de l'événement
    Terminated
  • Pays de l'événement
    United States
  • Date de fin de l'événement
    2011-07-29
  • Source de l'événement
    USFDA
  • URL de la source de l'événement
    https://www.accessdata.fda.gov/scripts/cdrh/cfdocs/cfres/res.cfm?id=100877
  • 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
    System, blood culturing - Product Code MDB
  • Cause
    Software contained three additional set configurations which caused the system to reinitialized the ast set carrier defaults.
  • Action
    BD Diagnostic Systems verbally notified all affect customers via the telephone on March 28, 2011. The notification identified the product, the problem, and the action to be taken by the customer. An "URGENT PRODUCT RECALL" follow-up letter was mailed to all customers on April 8, 2011 via UPS. Customers were instructed to complete and fax the attached reply form to acknowledge their receipt of the notification to Regulatory Compliance, 410-316-4256. The letter instructs customers to refer to the modified release notes and IMPORTANT NOTICES outlined in the attached notification letter. If further assistance is needed regarding replacements and all other inquires, please contact BD Technical Services and Support at 1-800-638-8663.

Device

Device Recall BD BACTEC(tm) MGIT (tm) 960 System
  • Modèle / numéro de série
    Lot number V5.02A, Catalog #445922
  • Classification du dispositif
    Immunology and Microbiology Devices
  • Classe de dispositif
    1
  • Dispositif implanté ?
    No
  • Distribution
    Nationwide Distribution (USA) including states of: AK, AL, AR, CA, CO, CT, DE, FL, GA, HI, IA, IL, IN, KS, KY, LA, MA, MD, MN, MO, MS, MT, NC, NE, NH, NJ, NM, NV, NY, OH, OK, OR, PA, RI, SC, SD, TN, TX, UT, VA, WA, and WI.
  • Description du dispositif
    BD BACTEC(tm) MGI (tm) System Software, Catalog 445922, Lot V5.02A. || Product Usage: The BACTEC(tm) MGIT (tm) System Software is used in the MGIT 960 and MGIT 320 instruments for the rapid detection of mycobacteria from clinical specimens. In addition, an Antimicrobial/Drug Susceptibility Testing (AST or DST) system is used as a rapid qualitative procedure for susceptibility testing of Mycobacterium tuberculosis, from culture, to streptomycin, isoniazid, rifampin, ethambutol, and pyrazinamide. The routine AST set consists of a Growth Control tube and a tube for each drug, as well as a barcoded tube carrier that holds the set. The carrier barcode provides set size and identification. A tube rack capable of holding up to 55 AST tubes in various set combinations is available for tube setup and transport. Large or small AST carrier sets can be placed in the rack. The MGIT AST system is based on growth of the Mycobacterium tuberculosis strain under test as measured by the instrument. AST sets are entered into the BACTEC MGIT instrument and are tested automatically. Analysis of fluorescence in a drug containing tube is compared to the fluorescence of the Growth Control tube to determine susceptibility results.
  • Manufacturer
    Becton Dickinson & Co.

Manufacturer

Becton Dickinson & Co.
  • Adresse du fabricant
    Becton Dickinson & Co., BD Diagnostic Systems, 7 Loveton Circle, Sparks MD 21152-0999
  • Société-mère du fabricant (2017)
    Becton, Dickinson and Company
  • Source
    USFDA