Events

Rappel de Device Recall Vitek 2 ASTP635 REF 416 911

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
    70645
  • Classe de risque de l'événement
    Class 3
  • Numéro de l'événement
    Z-1401-2015
  • Date de mise en oeuvre de l'événement
    2015-02-25
  • Date de publication de l'événement
    2015-04-08
  • Statut de l'événement
    Terminated
  • Pays de l'événement
    United States
  • Date de fin de l'événement
    2017-03-22
  • Source de l'événement
    USFDA
  • URL de la source de l'événement
    https://www.accessdata.fda.gov/scripts/cdrh/cfdocs/cfres/res.cfm?id=134235
  • 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
    Susceptibility test cards, antimicrobial - Product Code LTW
  • Cause
    The outer carton label and package insert for the recalled product incorrectly lists streptococcus pneumoniae as an organism for intended use.
  • Action
    Biomerieux, Incs sent an Urgent Product Correction Notice on February 25, 2015, to all affected customers. The letter identified the product, the problem, and the actions to be taken by the customer. Customers were instructed to do the following: " Please confirm this letter has been distributed and reviewed by all appropriate personnel within your organization. " For the referenced test kits (VITEK¿ 2 ASTP635, ASTP640 or ASTP641), review the claimed organisms in the Package Insert antibiotic table to confirm which organisms can be tested. " Refrain from using the referenced test kits to determine the susceptibility of Streptococcus pneumoniae. " Reference your Laboratory Standard Operating Procedures to identify card type used for specific organisms. " Please store this letter with your bioM¿rieux instrument documentation. Please complete the attached Acknowledgement Form and return it to bioM¿rieux, Inc. Customers with questions were instructed to contact their local BioMerieux representative. For questions regarding this recall call 314-731-8526.

Device

Device Recall Vitek 2 ASTP635 REF 416 911
  • Modèle / numéro de série
    lot 735352820, expiration 11AUG16; lot 735348620, expiration 30JUN16; lot 735346520, expiration 09JUN16; lot 735342320; expiration 28APR16; lot 735318020, expiration 29AUG15; lot 735315920, expiration 08AUG15; lot 735323710, expiration 25OCT15; lot 735310210, expiration 12JUN15
  • Classification du dispositif
    Immunology and Microbiology Devices
  • Classe de dispositif
    2
  • Dispositif implanté ?
    No
  • Distribution
    Worldwide Distribution to United Kingdom and Turkey. NO U.S. distribution.
  • Description du dispositif
    Vitek 2 AST-P635 REF 416 911 Gram Positive Susceptibility Card, 20 cards per container, IVD. || Intended for use with the Vitek 2 Systems in clinical laboratories as an in vitro test to determine the susceptibility of Staphylococcus spp., Enterococcus spp., and S. agalactiae.
  • Manufacturer
    Biomerieux Inc

Manufacturer

Biomerieux Inc
  • Adresse du fabricant
    Biomerieux Inc, 595 Anglum Rd, Hazelwood MO 63042-2320
  • Société-mère du fabricant (2017)
    Compagnie Merieux Alliance
  • Source
    USFDA