Events

Rappel de Device Recall Etest CEFOTAXIME CT 256

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 SA.

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
    71475
  • Classe de risque de l'événement
    Class 2
  • Numéro de l'événement
    Z-1947-2015
  • Date de mise en oeuvre de l'événement
    2015-06-12
  • Date de publication de l'événement
    2015-07-01
  • Statut de l'événement
    Terminated
  • Pays de l'événement
    United States
  • Date de fin de l'événement
    2017-08-01
  • Source de l'événement
    USFDA
  • URL de la source de l'événement
    https://www.accessdata.fda.gov/scripts/cdrh/cfdocs/cfres/res.cfm?id=137920
  • 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
    Manual antimicrobial susceptibility test systems - Product Code JWY
  • Cause
    Qc results were out of range resulting in false resistant strains.
  • Action
    BioMerieux sent an Urgent Product Removal Notices dated June 12, 2015, to all affected customers. The letter identified the product the problem and the action needed to be taken by the customer. Required actions: ¿¿ Please distribute this information to all appropriate personnel in your laboratory, retain a copy in your files, and forward this information to all parties that may use this product, including others to whom you may have transferred our product. ¿¿ Discontinue using and discard any remaining inventory of Etest¿¿ CEFOTAXIME CT 256 lots reported in table 1. ¿¿ Discuss any concerns you may have regarding previously reported results with your Laboratory Medical Director to determine the appropriate course of action. ¿¿ Complete and return the Acknowledgement Form in Attachment A by Fax to confirm receipt of this notice and to request product replacement. bioM¿¿rieux is committed to providing our customers with the highest quality product possible. We sincerely apologize for any inconvenience that this may have caused you. If you require additional assistance or have any questions, please contact your local bioM¿¿rieux Clinical Customer Service organization at (800) 682-2666.

Device

Device Recall Etest CEFOTAXIME CT 256
  • Modèle / numéro de série
    1002774320, 1002377890, 1002590470, 1002775330, 1002379610
  • Classification du dispositif
    Immunology and Microbiology Devices
  • Classe de dispositif
    2
  • Dispositif implanté ?
    No
  • Distribution
    Worldwide Distribution - USA (nationwide) to the states of AL, AR, CA, CO, FL, GA, IL, IN, KY, MD, MI, MN, MO, NE, NY, NC, OH, OK, OR, PA, TN, TX, UT, VA, WA, WV and WI., and to the countries of: Austria, Australia, Canada, Switzerland, Germany, Spain, France, United Kingdom, Greece, Hong Kong, India, Italy, Japan, Netherlands, Poland, Sweden, Thailand, Turkey, Saudi Arabia, Philippines, Slovenia, Kuwait, Brazil, Chile, Czech Republic, Algeria, South Africa, Kosovo, Costa Rica, Belarus, Guam, Honduras and Vietnam.
  • Description du dispositif
    Etest Cefotaxime CT 256 WW and Etest Cefotaxime CT 256 US. in vitro diagnostic.
  • Manufacturer
    BioMerieux SA

Manufacturer

BioMerieux SA
  • Adresse du fabricant
    BioMerieux SA, Chemin De L'Orme, Marcy L'Etoile France
  • Société-mère du fabricant (2017)
    Compagnie Merieux Alliance
  • Source
    USFDA