Events

Rappel de Device Recall BD BBL Vancomycin Screen Agar

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
    69062
  • Classe de risque de l'événement
    Class 2
  • Numéro de l'événement
    Z-2628-2014
  • Date de mise en oeuvre de l'événement
    2014-07-28
  • Date de publication de l'événement
    2014-09-12
  • Statut de l'événement
    Terminated
  • Pays de l'événement
    United States
  • Date de fin de l'événement
    2016-01-07
  • Source de l'événement
    USFDA
  • URL de la source de l'événement
    https://www.accessdata.fda.gov/scripts/cdrh/cfdocs/cfres/res.cfm?id=129481
  • 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
    These lots of agar may have exhibited breakthrough growth of vancomycin susceptible enterococcus species control organisms. agar that allows susceptible enterococci to grow appears as a falsely resistant culture. if a lab does not qc, the error would be identified as falsely resistant enterococci would have further ast workup. there could be a delay in the identification of false-resistance.
  • Action
    BD Diagnostic System sent an Urgent Product Recall letter dated July 2014, to all affected customers. The letter identified the product the problem and the action needed to be taken by the customer. Our records indicate you may have been shipped the above-referenced lot numbers of product between March 5, 2014 and June 5, 2014. Please discontinue use of these lot numbers and discard any remaining packages. If further assistance is needed, please contact BD Technical Services Department at 1-800-638-8663. The acknowledgement form included with the follow up letter that is faxed back to BD will be reconciled with the customer list. BD will contact 10% of non-respondents to verify receipt of the customer letter. BD has asked distributors to send their customer list to BD for follow up.

Device

Device Recall BD BBL Vancomycin Screen Agar
  • Modèle / numéro de série
    Lot numbers -  4080291 4042217 4048040 4052349 4058242 4073274 4127728
  • Classification du dispositif
    Immunology and Microbiology Devices
  • Classe de dispositif
    2
  • Dispositif implanté ?
    No
  • Distribution
    Worldwide Distribution: US (Nationwide) including the states of AK, AL, AR, AZ, CA, CO, CT, DC, DE, FL, GA, HI, IA, ID, IL, IN, KS, KY, LA, MA, MD, ME, MI, MN, MO, MS, MT, NC, ND, NE, NH, NJ, NM, NV, NY, OH, OK, OR, PA, RI, SC, TN, TX, UT, VA, VT, WA, WI and WV; and Internationally to the countries of Belgium, Canada, Colombia, India, Mexico, Singapore and Taiwan.
  • Description du dispositif
    BD BBL Vancomycin Screen Agar Catalog number 222204 || Vancomycin Screen Agar is used to test enterococci for resistance to vancomycin and to predict the synergistic activity of this antimicrobial with an aminoglycoside antimicrobial.
  • Manufacturer
    Becton Dickinson & Co.

Manufacturer

Becton Dickinson & Co.
  • Adresse du fabricant
    Becton Dickinson & Co., 7 Loveton Cir, BD Diagnostic Systems, Sparks MD 21152-9212
  • Société-mère du fabricant (2017)
    Becton, Dickinson and Company
  • Source
    USFDA