Events

Rappel de BD ProbeTec" CT/GC/AC 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
    58875
  • Classe de risque de l'événement
    Class 2
  • Numéro de l'événement
    Z-2658-2011
  • Date de publication de l'événement
    2011-06-24
  • Statut de l'événement
    Terminated
  • Pays de l'événement
    United States
  • Date de fin de l'événement
    2011-06-24
  • Source de l'événement
    USFDA
  • URL de la source de l'événement
    https://www.accessdata.fda.gov/scripts/cdrh/cfdocs/cfres/res.cfm?id=100457
  • 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
    DNA probe, nucleic acid amplification, chlamydia - Product Code MKZ
  • Cause
    In vitro diagnostic reagent packs may be underfilled and contribute to invalid quality control testing or false positive patient results.
  • Action
    BD Diagnostic Systems sent an "URGENT PRODUCT RECALL" letter dated September 2010 to all affected customers. The letter describes the product, problem, and the actions to be taken by the customers. Customers were instructed to discontinue use of the product and discard any remaining product. BD will replace any discarded products. Additionally, customers were requested to complete and return an attached form whether or not they have any inventory remaining, to confirm receipt of the notification. The letter instructed the customers to fax the completed form to: Attention: Regulatory Compliance at 410-316-4258. For assistance regarding replacements, contact BD Customer Service Department at 1-800-675-0908. All other inquiries should contact BD Technical Services Department at 1-800-638-8663.

Device

BD ProbeTec" CT/GC/AC Reagent Pack
  • Modèle / numéro de série
    Lot 0158908 exp May 31, 2011 and Lot 0158969 exp May 31, 2011
  • Classification du dispositif
    Immunology and Microbiology Devices
  • Classe de dispositif
    1
  • Dispositif implanté ?
    No
  • Distribution
    Worldwide Distribution--USA (nationwide) including the states of AL, CA, CO, CT, FL, GA, KY, LA, ME, MN, MO, MS, MT, NE, OH, PA, RI, TX, and WA and the countries of Australia, Canada, Europe, and Japan.
  • Description du dispositif
    BD ProbeTec" CT/GC/AC Reagent Pack, catalog #440450, labeled in part ***Becton Dickinson and Company, 7 Loveton Circle, Sparks, MD 21152*** || The BD ProbeTec" ET Chlamydia trachomatis and Neisseria gonorrhoeae Amplified DNA Assays, when tested with the BD ProbeTec ET System, use Strand Displacement Amplification (SDA) technology for the direct, qualitative detection of Chlamydia trachomatis and Neisseria gonorrhoeae DNA in endocervical swabs, male urethral swabs, and in female and male urine specimens as evidence of infection with C. trachomatis, N. gonorrhoeae, or of co-infection with both C. trachomatis and N. gonorrhoeae. Specimens may be from symptomatic or asymptomatic females and males. A separate Amplification Control is an option for inhibition testing (BD ProbeTec ET CT/GC/AC Reagent Pack). The BD ProbeTec ET CT/GC assays may be performed using either the BD ProbeTec ET System or a combination of the BD ProbeTec ET System and BD Viper" instrument.
  • 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