Events

Rappel de Device Recall BD Phoenix PMIC107

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
    77370
  • Classe de risque de l'événement
    Class 2
  • Numéro de l'événement
    Z-0171-2018
  • Date de mise en oeuvre de l'événement
    2017-05-11
  • Statut de l'événement
    Terminated
  • Pays de l'événement
    United States
  • Date de fin de l'événement
    2018-02-06
  • Source de l'événement
    USFDA
  • URL de la source de l'événement
    https://www.accessdata.fda.gov/scripts/cdrh/cfdocs/cfres/res.cfm?id=155855
  • 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
    System, test, automated, antimicrobial susceptibility, short incubation - Product Code LON
  • Cause
    Bd has recently confirmed quality control failures, related to a manufacturing issue, for the inducible macrolide-linosamide-streptogramin b (imlsb) test contained on lot 7031818 of phoenix panels. the imlsb resistance d-test screen for staphylococcus species is used to identify phenotypic drug resistance to clindamycin and erythromycin. as the product should not be used when quality control (qc) fails, it is unlikely that there would be any impact on patient results, however, if a customer does not perform qc testing and uses the panel, there is a potential to incorrectly treat a staphylococcus infection with clindamycin based on the imlsb test result. this issue can be detected 100% of the time when used per package insert instructions with imlsb positive strain s. aureus baa-977.
  • Action
    URGENT PRODUCT RECALL LETTER (dated May 2017) were sent to customers via a UPS mailing on May 11, 2017. Customers were instructed to discontinue use of the affected lot and discard any remaining product. BD will replace the discarded inventory. Please complete the attached Customer Response Form and return to the BD contact noted on the form whether or not you have any of the impacted material so that BD may acknowledge your receipt of this notification and process your product replacement. Please complete and fax the form to: Attention: Regulatory Compliance, Fax: 410-316-4258 or e-mail to: BDRC2@bd.com. For further assistance, please contact BD (Customer/Technical) Support at 1-800-638-8663 in the USA.

Device

Device Recall BD Phoenix PMIC107
  • Modèle / numéro de série
    Lot 7031818, Exp. Date 2/28/2018
  • Classification du dispositif
    Immunology and Microbiology Devices
  • Classe de dispositif
    2
  • Dispositif implanté ?
    No
  • Distribution
    CT, VA, PA, TX, FL, NC, WI, NM
  • Description du dispositif
    BD Phoenix PMIC-107, Catalog Number 448417, UDI #s (01)30382904484171, (10)7031818(17)180228(30)0025, IVD. || PMIC-107 is a Gram positive AST Only panel used to test antibiotic susceptibility. The inducible macrolide-linosamide-steptogramin B (iMLSb) resistance D-test screen for Staphylococcus species is used to identify phenotypic drug resistance to clindamycin and erythromycin. --- Product is packaged 25 panels to 1 box.
  • Manufacturer
    Becton Dickinson & Co.

Manufacturer

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