Events

Rappel de Device Recall BD ProbeTec Neisseria gonorrhoeae (GC) Qx Amplified DNA Assay Reagent Pack

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
    64444
  • Classe de risque de l'événement
    Class 2
  • Numéro de l'événement
    Z-1215-2013
  • Date de mise en oeuvre de l'événement
    2013-02-08
  • Date de publication de l'événement
    2013-05-03
  • Statut de l'événement
    Terminated
  • Pays de l'événement
    United States
  • Date de fin de l'événement
    2013-05-13
  • Source de l'événement
    USFDA
  • URL de la source de l'événement
    https://www.accessdata.fda.gov/scripts/cdrh/cfdocs/cfres/res.cfm?id=116151
  • 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
    Culture media, for isolation of pathogenic neisseria - Product Code JTY
  • Cause
    Increased levels of false positives in bd probe tech neisseria gonorrhoeae q amplified dna assay kits.
  • Action
    BD Diagnostic Systems sent an "URGENT PRODUCT RECALL" letter via UPS overnight delivery on February 8, 2013. The letter identified the product, the problem, and the action to be taken by the customer. Customers were instructed to verify that these kits have been consumed, returned or destroyed by completing the enclosed form. The firm will issue a no charge replacement for customers' product. Any product remaining in customers' inventory should be discarded or destroyed per their facility procedures. Complete the attached form regardless if any inventory remains, so that the firm may acknowledge customers' receipt of this notification. It is not necessary to contact BD by telephone to receive replacements. Complete and fax the form to: Attention: Regulatory Compliance, Fax: 410-316-4258 OR E-mail to RegulatoryComplianceFax@BD.com. If further assistance is needed regarding replacements, please contact BD Customer Service Department at 1-800-675-0908.

Device

Device Recall BD ProbeTec Neisseria gonorrhoeae (GC) Qx Amplified DNA Assay Reagent Pack
  • Modèle / numéro de série
    Lot No./Exp. Date: 2237214 / 2013-10-31.
  • Classification du dispositif
    Immunology and Microbiology Devices
  • Classe de dispositif
    2
  • Dispositif implanté ?
    No
  • Distribution
    Distributed in the states of CA, FL, GA, NJ, and TX.
  • Description du dispositif
    BD ProbeTec Neisseria gonorrhoeae (GC) Qx Amplified DNA Assay Reagent Pack, REF 441124, contains 12 each Microwells labeled in part ***BD ProbeTec Neisseria gonorrhoeae (GC) Qx Amplified DNA Assay Reagent Pack REF 441124 ***For use with the BD Viper System *** Becton, Dickinson and Company 7 Loveton Circle, Sparks, MD 21152 USA www.bd.com/ds EC REP Benex Limited, Pottery Road, Dun Laoghaire, Co. Dublin, Ireland. || Assay is indicated for use with asymptomatic and symptomatic individuals to aid in the diagnosis of gonococcal urogenital disease.
  • 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