Events

Rappel de VITEK 2 Gram Negative Susceptibility Card, ASTN183

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 Biomerieux 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
    58135
  • Classe de risque de l'événement
    Class 1
  • Numéro de l'événement
    Z-2049-2011
  • Date de mise en oeuvre de l'événement
    2011-04-04
  • Date de publication de l'événement
    2011-04-27
  • Statut de l'événement
    Terminated
  • Pays de l'événement
    United States
  • Date de fin de l'événement
    2012-06-01
  • Source de l'événement
    USFDA
  • URL de la source de l'événement
    https://www.accessdata.fda.gov/scripts/cdrh/cfdocs/cfres/res.cfm?id=98448
  • 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, test, automated, antimicrobial susceptibility, short incubation - Product Code LON
  • Cause
    The piperacillin/tazobactam drug on the antimicrobial susceptibility cards is providing false susceptible and false resistant results for e. coli, as well as an additional 7 organisms; and the same drug is providing false resistant results for k. pneumoniae.
  • Action
    BioMerieux sent an Urgent Product Correction Notice (EXPANDED RECALL), VITEK 2 Piperacillin/Tazobactam Test, Document #9300786," letter dated March 30, 2011, via Fed EX on April 4, 2011. to all affected customers. The letter describes the issues, how the issues impact the test results, describes the product changes that are going to take place, and provides instructions on required actions to be taken. The product changes will involve the eventual changeover to new cards that will be created which do not contain Piperacillin/Tazobactam (TZP2). The new cards will begin shipping by July 16, 2011, but in the meantime, the cards currently in possession of the customers can be used with specific required actions that need to be followed. Until the TZP redevelopment is completed and a resolution can be implemented, BioMerieux requires their customers to immediately take the following actions: The customers will be required to suppress the TZP2 resistant and susceptible results for Escherichia coli, Morganella morganii, Proteus mirabilis, Proteus vulgaris, Providencia rettgeri, Providencia stuartii, Pseudomonas aeruginosa, and Salmonella enterica and use an alternate method of testing. In addition, the customer is to suppress the TZP2 resistant result only for Klebsiella pneumonia and use an alternate method of testing. The letter provides instructions for configuring the VITEK 2 software to suppress the results from reporting. The instructions contained in the recall notification are to be applied to all current and future product lots that contain TZP2 until further notice. The customer is to complete the enclosed acknowledgement form and return it via FAX to acknowledge receipt of the notification and is requested to file the correction notice with their VITEK 2 Systems permanent records according to their internal policy or procedure. For questions or additional information customers were instructed to call 1-800-682-2666, option 3. In addit

Device

VITEK 2 Gram Negative Susceptibility Card, ASTN183
  • Modèle / numéro de série
    All lot numbers
  • Classification du dispositif
    Immunology and Microbiology Devices
  • Classe de dispositif
    2
  • Dispositif implanté ?
    No
  • Distribution
    There was no U.S. distribution as the cards were for export only to Canada and Sweden.
  • Description du dispositif
    VITEK 2 Gram Negative Susceptibility Card, AST-N183, REF 411 021, For In Vitro Diagnostic Use, 20 cards/box. The firm names on the label are bioMerieux, Inc., Durham, NC, and bioMerieux sa, Marcy-l'Etoile France. || The cards are intended for use with the Vitek 2 systems in clinical laboratories as an in vitro test to determine the susceptibility of clinically significant aerobic/anaerobic gram-negative bacilli to antimicrobial agents.
  • Manufacturer
    Biomerieux Inc

Manufacturer

Biomerieux Inc
  • Adresse du fabricant
    Biomerieux Inc, 595 Anglum Rd, Hazelwood MO 63042
  • Société-mère du fabricant (2017)
    Compagnie Merieux Alliance
  • Source
    USFDA