Events

Rappel de Device Recall BD MAX MRSA Assay

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
    68991
  • Classe de risque de l'événement
    Class 2
  • Numéro de l'événement
    Z-2618-2014
  • Date de mise en oeuvre de l'événement
    2014-07-23
  • Date de publication de l'événement
    2014-09-10
  • Statut de l'événement
    Terminated
  • Pays de l'événement
    United States
  • Date de fin de l'événement
    2016-05-09
  • Source de l'événement
    USFDA
  • URL de la source de l'événement
    https://www.accessdata.fda.gov/scripts/cdrh/cfdocs/cfres/res.cfm?id=129213
  • 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, nucleic acid amplification test, dna, methicillin resistant staphylococcus aureus, direct sp - Product Code NQX
  • Cause
    The performance of the assay no longer conforms to this statement in the analytical specificity section of the package insert: one hundred-eleven (111) out of 111 mssa strains tested at extremely high concentrations (> 106 cfu/swab), produced negative results with the bd max mrsa assay. one of the samples tested with each of the cap surveys mrs5-a 2014 and mrs5-b 2014 yielded false positive results.
  • Action
    Becton Dickinson sent an Field Correction Notification initiated on July 23, 2014. US customers were contacted via letters sent by UPS. The letter identified the product the problem and the action needed to be taken by the customer. 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. Any product returned to BD will be quarantined and discarded. Nonetheless, you may observe some false positive results for MSSA strains when using the above referenced product. Please contact the BD Technical Service Department at 1-800-638-8663 if you have observed an increase in MSSA false positive results or have failed the above referenced CAP surveys.

Device

Device Recall BD MAX MRSA Assay
  • Modèle / numéro de série
    All Lots with the expiration date January 21, 2014 or later
  • Classification du dispositif
    Immunology and Microbiology Devices
  • Classe de dispositif
    2
  • Dispositif implanté ?
    No
  • Distribution
    US Distribution including the states of : CA, FL, HI, IL, IN, MD, MI, MN, MT, NC, ND, NJ, NM, NV, NY, OH, OK, OR, PA, SC, TN, TX, UT, VA, WA and WI.
  • Description du dispositif
    The BD MAX MRSA Assay, catalogue #442953. || An automated qualitative in vitro diagnostic test for the direct detection of Methicillin-resistant Staphylococcus aureus (MRSA) DNA from nasal swabs in patie.
  • 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