Events

Rappel de Device Recall HardyCHROM MRSA

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 Hardy Diagnostics.

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
    71804
  • Classe de risque de l'événement
    Class 2
  • Numéro de l'événement
    Z-2463-2015
  • Date de mise en oeuvre de l'événement
    2015-07-09
  • Date de publication de l'événement
    2015-08-26
  • Statut de l'événement
    Terminated
  • Pays de l'événement
    United States
  • Date de fin de l'événement
    2015-11-10
  • Source de l'événement
    USFDA
  • URL de la source de l'événement
    https://www.accessdata.fda.gov/scripts/cdrh/cfdocs/cfres/res.cfm?id=139127
  • 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, antimicrobial susceptibility test, excluding mueller hinton agar - Product Code JSO
  • Cause
    Hardy diagnostics is recalling hardychrom mrsa due to a report of the potential for breakthrough of the methicillin-sensitive staphylococcus aureus (mssa) qc strain, atcc 29213 on the identified lot.
  • Action
    The firm initially notified customers via phone to inform them of a recall. The phone scripts asks customers if they have had any issued with the QC testing. The firm states that our of a precaution they are asking customers to discard the remaining plates of the identified lot, and that credit or replacement plates will be offered for any remaining. The firm followed-up phone calls with a written notification letter. The letter states to complete, sign, and fax or email back the enclosed form stating compliance with the above action. The letters states that is the customer could not be reached via phone and would like replacements or credit to contact the Customer Service Department at 800-266-2222, option 1. Any questions call the Technical Services Department at 800-266-2222, option 2 or email at techservice@hardy diagnostics.com.

Device

Device Recall HardyCHROM MRSA
  • Modèle / numéro de série
    Cat no. G307 Lot no. H15155
  • Classification du dispositif
    Immunology and Microbiology Devices
  • Classe de dispositif
    2
  • Dispositif implanté ?
    No
  • Distribution
    Distributed in the states of VA, PA, NY, NJ, IL, OH, and MD.
  • Description du dispositif
    HardyCHROM MRSA || Cat no: G307 Lot no: H15155 || Expires: 2015-08-13 || Container Type: 15x100mm monoplate || Packaged: 10 plates/sleeve || Storage: 2-8C on receipt. Light Sensitive. || In vitro diagnostic || www.HardyDiagnostics.com
  • Manufacturer
    Hardy Diagnostics

Manufacturer

Hardy Diagnostics
  • Adresse du fabricant
    Hardy Diagnostics, 1430 W Mccoy Ln, Santa Maria CA 93455-1005
  • Société-mère du fabricant (2017)
    Hardy Diagnostics
  • Source
    USFDA